Great job opportunity for a CLINICAL REASRCH PROEJCT LEADER for one of the most reputable, full-service providers of CRO and SMO.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a proven professional to obtain the role with a flying start and deep dive into the daily tasks with confidence and knowledge.

What is expected to be done?

• Monitor and manage project milestones and timelines as per the contract obligations;
• Determine project-specific oversight metrics, as needed, in agreement with the client;
• Perform risk assessment and propose mitigation strategy for the project;
• Prepare, oversee, and review documents related to assigned clinical research project;
• Provide regular updates of project status to the client and operational team;
• Ensure effective and proper communication between all parties involved in the project;
• Coordinate and conduct internal kick-off meeting as well as of kick-off meeting with the client;
• Organize and supervise of project-specific training;
• Oversee and control all logistic procedures related to the study and serve as a signal point of contact for the management and client;
• Fully involved in resolving project issues, as well as take part in procedure improvement initiatives;
• Supervise of project submission/approval process to EC/RA
• Support quality group in preparation of project-specific audit as needed
• Translation of project-specific documents, when necessary
• Participate in marketing activities, client presentations, and proposal development

What is required for the role?

• Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
• Minimum 3 years of experience in the leading role in a clinical research filed;
• Excellent knowledge of clinical research process;
• Excellent knowledge of current ICH/GCP guidelines and country-specific regulations;
• Exceptional problem-solving, organizational, and leadership skills;
• Outstanding communication skills – able to successfully convey massages across both dedicated team and external teams involved in the clinical research;
• Ability to keep deadlines for multiple projects in a demanding working environment;
• Ability to pay attention to details, absorb and analyse specific project data;
• Working knowledge of Word, Excel, and Power Point;
• Fluency in English language;

Why to join Comac Medical?

• Great team of knowledgeable, high-achieving and experienced professionals;
• International and diverse work atmosphere;
• Challenging projects in a different therapeutical area as well as in early phases;
• Opportunity to enrich professional skills and progress in career development;
• Work from home policy
• Competitive remuneration;
• Additional health insurance and food vouchers;
• Professional trainings;

Core strengths of Comac Medical

• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Great job opportunity for a CLINICAL RESEARCH ASSOCIATE for one of the most reputable, full-service providers of CRO and SMO, COMAC MEDICAL,  with headquarter in Sofia, Bulgaria.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, we are a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a professional to join our Hungarian Team

What is expected to be done:

• Conducts feasibility studies and site qualification visits;
• Develops and ensures strong site relationship through all phases of the trial;
• Gains in-depth understanding of the study protocol and related procedures;
• Prepares study documentation e.g. draft protocols, draft CRFs;
• Collects, reviews, and monitors required regulatory documentation;
• Communicates with Investigators and site staff on issues related to protocols;
• Conducts recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
• Performs remote and on-site monitoring & oversight activities;
• Identifies, assesses and resolves site performance, quality or compliance problems
• Escalates if necessary, by following CRA Escalation Pathway in collaboration with CTL/CMM/PL;
• Assists in planning and execution of Investigator Meetings or other study related meetings;
• Assume additional responsibilities as required by Project Manager;

What is required for the role?

• Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
• At least 3 years of experience as a Clinical Research Associate/Clinical Monitor;
• Excellent knowledge of clinical research process;
• Good knowledge of all functional areas of clinical trial management;
• Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations;
• Excellent organizational, communication (verbal and written)
• Positive attitude and ability to interact with various levels of personnel
• Good analytical and problem-solving skills;
• Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%)
• Ability to keep tight deadlines and work in a dynamic environment;
• Working knowledge of Word, Excel, and Power Point
• Fluency in English language

Why to join Comac Medical?

• Great team of knowledgeable, high-achieving and experienced professionals;
• International and diverse work atmosphere;
• Challenging projects in a different therapeutic area as well as in early phases;
• Opportunity to enrich professional skills and progress in career development;
• Competitive remuneration;
• Professional trainings;

Core strengths of Comac Medical

• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Great job opportunity for a Data Manager for one of the most reputable, full-service providers of CRO and SMO.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently, we are looking for an inspiring Leader to join our Data Management team of highly achieved and dedicate professionals.

 What is expected to be done?

• Act as Lead Data Manager, coordinate data management team to successful completion of clinical trial projects within given timelines;
• Interact with clients and project manager as main contact person
• Prepare and review paper CRF, annotated CRF, EDC specification, Data Validation Specification, Data Management Plan
• Set-up and validate the study-specific clinical database;
• Develop CRF Completion Guidelines;
• Supervise double data entry process;
• Monitor coding and medical review processes related to clinical database
• Prepare Data Transfer Agreements;
• Perform QC of the database in case of double data entry;
• Track and clean the data in the clinical database;
• Prepare of study specific data management documents for trial master file;
• Assist Quality Group in preparation of data management SOPs;
• Support Quality Group in preparation of audit on the Data Management activities;

What is required for the role?

• University degree in Mathematics, Computer Science or relevant fields;
• At least 2 years of experience in Data Management in the clinical trial settings;
• Thorough knowledge of current ICH/GCP guidelines and applicable regulations;
• Strong working knowledge of SDTM, CDISC controlled terminology;
• Experience with SAS and/or SQL;
• Excellent analytical capabilities, inclination to non-standard problem solving;
• Excellent organizational, communication and interpersonal skills;
• Positive attitude and ability to interact with all levels of staff;
• Proficiency in English;
• Ability to keep and work with tight deadlines;

Why to join Comac Medical?

• Great team of knowledgeable, high-achieving, and experienced professionals;
• International and diverse work atmosphere;
• Challenging projects in a different therapeutical area as well as in early phases;
• Opportunity to enrich professional skills and progress in career development;
• Work from home policy
• Competitive salary and social benefits;

Core strengths of Comac Medical:

• Dedicated state-of-art Phase I Unit;
• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;

 Do not ignore this opportunity! Check it out!

I will be glad to speak to you and give you more details about the company, projects, values, people etc

Great job opportunity for a CLINICAL RESEARCH ASSOCIATE for one of the most reputable, full-service providers of CRO and SMO, COMAC MEDICAL,  with headquarter in Sofia, Bulgaria.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, we are a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a professional to join our Croatian Team

What is expected to be done:

• Conducts feasibility studies and site qualification visits;
• Develops and ensures strong site relationship through all phases of the trial;
• Gains in-depth understanding of the study protocol and related procedures;
• Prepares study documentation e.g. draft protocols, draft CRFs;
• Collects, reviews, and monitors required regulatory documentation;
• Communicates with Investigators and site staff on issues related to protocols;
• Conducts recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
• Performs remote and on-site monitoring & oversight activities;
• Identifies, assesses and resolves site performance, quality or compliance problems
• Escalates if necessary, by following CRA Escalation Pathway in collaboration with CTL/CMM/PL;
• Assists in planning and execution of Investigator Meetings or other study related meetings;
• Assume additional responsibilities as required by Project Manager;

What is required for the role?

• Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
• At least 3 years of experience as a Clinical Research Associate/Clinical Monitor;
• Excellent knowledge of clinical research process;
• Good knowledge of all functional areas of clinical trial management;
• Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations;
• Excellent organizational, communication (verbal and written)
• Positive attitude and ability to interact with various levels of personnel
• Good analytical and problem-solving skills;
• Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%)
• Ability to keep tight deadlines and work in a dynamic environment;
• Working knowledge of Word, Excel, and Power Point
• Fluency in English language

Why to join Comac Medical?

• Great team of knowledgeable, high-achieving and experienced professionals;
• International and diverse work atmosphere;
• Challenging projects in a different therapeutic area as well as in early phases;
• Opportunity to enrich professional skills and progress in career development;
• Competitive remuneration;
• Professional trainings;

Core strengths of Comac Medical

• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Great job opportunity for a Quality Management Specialist in one of the most reputable, full-service providers of CRO and SMO

Established in 1997, with locations in Central & Eastern Europe and over 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for the pharmaceutical industry.

Currently, we are looking for a professional to become part of our QG team and take an active role in the Quality Management Systems administration and support process.

What is expected to be done?

• Support Chief Compliance Officer in the implementation of a Clinical Quality Management System (QMS) that matches the development of the industry and regulatory demands for clinical regulations.
• Prepare and review an internal QMSD
• Ensure all internal and external QMSD are properly filed and distributed
• Help CCO in preparation of external audit and inspection
• Support CCO with regards to the CAPA related to QMS
• Serve as a quality responsible person in issue management

What is required for the role?

• To be a Graduate or postgraduate degree
• At least 2 years experience in quality management in a regulated environment / preferably in Clinical Trials
• Very good knowledge of current ICH/GCP guidelines & regulations
• Working knowledge of applicable ISO standards
• Excellent organizational, communication (verbal and written) and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff
• Ability to work with a tight deadline in a demanding business environment
• Fluency in English language
• Working knowledge of Word, Excel, and PowerPoint

Why join Comac Medical?

• You will be a part of a great team of knowledgeable, high-achieving, and experienced professionals;
• International and diverse work atmosphere
• Challenging projects in different therapeutical areas as well as in early phases
• Opportunity to enrich professional skills and progress in career development
• Work-from-home policy
• Competitive salary and social benefits – food vouchers 200 BGN, subsidized Multisport card, additional health insurance

Core strengths of Comac Medical:

• Dedicated state-of-art Phase I Unit
• Proven track record for quality and delivery
• Established and trusted relationships with KOLs
• Motivated, capable and dedicated team
• Global full-service capabilities

If you are interested, challenged, and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Great job opportunity for an IT Service Desk and QA Specialist in one of the most reputable, full-service providers of CRO and SMO

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for the pharmaceutical industry.

In this role, you will provide maintenance of the computer desktop environment by analyzing requirements, resolving problems, installing hardware and software solutions, and supporting the internal IT Help desk. You will be responsible for the administration and internal support of the Company’s PCs, printers, servers and related equipment. Tasks include end-user support, license tracking, and performing PC maintenance, upgrades and configurations.

What is expected to be done?

• Provide helpdesk support and resolve problems to the end user’s satisfaction
• Monitor and respond quickly and effectively to requests received through the IT help desk
• Respond to queries either in person or over the phone and monitor pending support requests based on priority
• Modify configurations, utilities, software default settings, etc. for the local workstation
• Utilize and maintain the asset management
• Assist with on-boarding of new users
• Train computer users and write training manuals, if needed
• Ensure each workstation is properly equipped
• Install, test and configure new workstations, peripheral equipment and software
• Maintain inventory of all equipment, software and software licenses
• Report issues to the IT Manager
• Assign users and computers to proper groups in Active Directory
• Perform timely workstation hardware and software upgrades as required
• Document internal and external procedures as well as some software systems
• Collaborate with development team members regarding testing strategies, plans and scheduled releases
• Support and help team members with automation QA tasks
• Analyse, describe and track defects in a bug tracking system
• Design, develop, maintain and improve test documentation
• Contribute to adjust Test Automation to a Continuous Delivery Process

What is expected of the role?

• University degree in IT specialty is preferable
• Excellent command of spoken and written English
• Previous experience in a similar position will be considered an advantage;
• Advanced knowledge of Windows OS and Linux OS
• Very good attention to detail, excellent analytical capabilities
• Responsible, pro-active, well-organized, and committed person, team player
• Ability to work under pressure and to keep tight deadlines
• Knowledge and experience in test case design end execution
• Experience with web applications manual and automation testing
• Knowledge and experience with testing methodologies and techniques and QA processes

Why join Comac Medical?

• Working for a successful international company, the opportunity for career development in a perspective professional field
• Competitive remuneration
• Friendly working environment
• Additional benefits – food vouchers, additional health insurance

Core strengths of Comac Medical:

• Dedicated state-of-art Phase I Unit
• Proven track record for quality and delivery
• Established and trusted relationships with KOLs
• Motivated, capable and dedicated team
• Global full-service capabilities

Do not ignore this opportunity! Check it out!

Only the short-listed candidates will be contacted in a timely manner.

Great job opportunity for a SITE COORDINATOR for one of the most reputable, full-service providers of CRO and SMO

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for the pharmaceutical industry.

Currently, we are looking for a professional to work closely with the CLINICAL SITE MANAGER, to coordinate clinical research studies activities, to streamline processes, administration and communication between teams involved in the study.

What is expected to be done?

• Support all types of feasibility inquiries at the respective site;
• Assist the site team with regards to subject pre-selection and recruitment;
• Help the site team in subjects’ visits planning and preparation;
• Organize various source of documentation;
• Complete Case Report Form and maintain Investigator Site File;
• Participate and coordinate any trainings and meetings (incl. Investigator Meetings) related to a specific study;
• Collaborate with the site team for any adverse events and safety information reporting and escalation;
• Organize and coordinate logistic of study medication, other study supplies and biological samples;
• Ensure timely site equipment maintenance and calibration;
• Handle subject expenses reimbursement;
• Support project team in the collection of site-specific documents;
• Support the site team in audit/inspection preparation, as needed

What is required for the role?

• Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
• One year of experience in the leading role in a clinical research filed;
• Very good knowledge of clinical research process;
• Sound knowledge of current ICH/GCP guidelines and country-specific regulations;
• Particularly good organizational and coordination skills;
• Excellent communication skills both written and spoken;
• Working knowledge of Word, Excel, and Power Point;
• Fluency in English language;

Why join Comac Medical?

• Great team of knowledgeable, high-achieving and experienced professionals;
• International and diverse work atmosphere;
• Challenging projects in a different therapeutical area as well as in early phases;
• Opportunity to enrich professional skills and progress in career development;
• Competitive remuneration;
• Additional health insurance and food vouchers;
• Professional trainings;

Core strengths of Comac Medical

• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;

If you are interested, challenged, and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Great job opportunity for a CLINICAL TRIAL ASSISTANT for one of the most reputable, full-service providers of CRO and SMO.

Established in 1997, with locations in Central & Eastern Europe and over, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for the pharmaceutical industry.

Currently, we are looking for a professional to work closely with our Project Leaders, coordinate clinical research project activities, and assist in streamlining processes and communication between parties involved.

What is expected to be done?

• Support Project Leaders in the organization of project-specific training, аs directed
• Support Project Leaders/Associate Project Leads in the creation and filing of project management documents
• Support Project Leaders/Associate Project Leads in the organization of internal kick-off meetings as well as kick-off meetings with the client
• Translation of project-specific documents, when necessary
• Assume additional responsibilities as directed by Project Manager

What is required for the role?

• Graduate or postgraduate degree
• Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations.
• Proficiency in English
• Ability to work under pressure and to keep tight deadlines
• Working knowledge of Word, Excel, and Power Point.

Why join Comac Medical?

• We are proud of our great team of knowledgeable, high-achieving, and experienced professionals
• You will be a part of an International and diverse work environment
• Be a part of challenging projects in a different therapeutic area as well as in early phases
• We offer a competitive remuneration
• You will receive and will participate in a number of training to enrich your professional knowledge

Core strengths of Comac Medical:

• Proven track record for quality and delivery
• Established and trusted relationships with KOLs
• Motivated, capable and dedicated team
• Global full-service capabilities

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Great job opportunity for a MEDICAL WRITING SPECLSIST for one of the most reputable, full-service providers of CRO and SMO. Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for the pharmaceutical industry.

Currently, we are looking to hire a professional to step into the role and contribute to the overall results of the company.

What is expected to be done:

• Creation or review of Clinical Study Protocols (for early and late phase clinical trials, non-interventional studies, PASS etc.);
• Participation in the creation of the Clinical Development Program;
• Creation or review of Participant information and Informed Consent Form;
• Preparation of clinical sections of New Drug Applications (NDAs);
• Preparation or review of Investigator Brochure;
• Preparation or review of Integrated Clinical Study Report (ICSR);
• Preparation or review of Manuscripts and posters;
• Preparation or review of other medical/technical documents, as directed.

What is required for the role?

• Graduate or postgraduate degree in Medical Sciences, Life Sciences, Biostatistics or another relevant field;
• At least 2 years’ experience in clinical research;
• Knowledge of regulations relevant to medical writing;
• Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results;
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner;
• Excellent organizational, communication (verbal and written) and interpersonal skills;
• Proficiency in English;
• Positive attitude and ability to interact with all levels of staff;
• Ability to keep tight deadlines;
• Working knowledge of Word, Excel, and Power Point;

Why join Comac Medical?

• We are proud of our great team of knowledgeable, high-achieving, and experienced professionals;
• You will be a part of an International and diverse work environment;
• Be a part of challenging projects in a different therapeutic area as well as in early phases;
• We offer a competitive remuneration;
• You will receive and will participate in a number of training to enrich your professional knowledge;

Core strengths of Comac Medical:

• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Great job opportunity for a REGIONAL REGULATORY LEAD for one of the most reputable, full-service providers of CRO and SMO.

Established in 1997, with locations in Central & Eastern Europe and over, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for the pharmaceutical industry.

Currently, we are looking for a professional to join our international team and obtain the key role of:

REGIONAL REGULATORY LEAD

What is expected to be done?

• Establish study regulatory strategy with the client and project team;
• Discuss and agree on the submission timelines for all countries in the region with the Project Leader and the client;
• Perform quality checks of clinical trial documentation prior to EC and RA submission as per the local requirements and applicable SOPs in close collaboration with the study team;
• Assist in resolving issues related to regulatory activities and requirements;
• Initiate and participate in internal discussions for any regulatory requirements and issues;
• Review project documents for regulatory completeness, consistency, and accuracy, and interact with project team members to assure completeness, as necessary;
• Serve as Project Regulatory Lead and/or Regulatory Affairs Specialist;
• Support Global Regulatory Affairs Manager in the maintenance of regulatory intelligence for all countries within the assigned region;
• Support Global Regulatory Affairs Manager in the implementation of the regulatory changes in the assigned region;
• Support the Global Regulatory Affairs Manager in preparations for interactions with HAs and assist operating teams with these interactions;
• Support the Global Regulatory Affairs Manager when needed to serve as the Regulatory representative on specific cross-functional teams and provide regulatory viewpoints and expertise to them (e.g.: Scientific team, Bioanalytical team etc.);

What is required for the role?

• Graduate or postgraduate degree;
• At least 3-years’ experience in the field of clinical trials and at least 2 years as a Regulatory Specialist/ Regulatory Affairs Associate;
• Working knowledge of current ICH/GCP guidelines, applicable regulations (including regional-specific ones), and current industry practices;
• Excellent organizational, communication (verbal and written) and interpersonal skills;
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings;
• Proficiency in English;
• Positive attitude and ability to interact with all levels of staff;
• Ability to keep tight deadlines and work in a demanding environment;
• Working knowledge of Word, Excel, and PowerPoint;

Why join Comac Medical?

• Great team of knowledgeable, high-achieving, and experienced professionals;
• International and diverse work environment;
• Challenging projects in a different therapeutic area as well as in early phases;
• Competitive remuneration;
• Additional health insurance, food vouchers and subsidized Multisport card;
• You will receive and will participate in a number of training to enrich your professional knowledge;

Core strengths of Comac Medical:

• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Great job opportunity for a START-UP ACTIVITIES LEAD for one of the most reputable, full-service providers of CRO and SMO

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, we are a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry

Currently we are looking for a professional to join our Bulgarian team as a START-UP ACTIVITIES LEAD

What is expected to be done?

• Oversee the execution of all regulatory submission activities for assigned projects
• Discuss and agree the submission timelines with the Project Leader and the client
• Align with the study team the regulatory expectations and parameters for submissions and all necessary authorizations
• Collect and prepare for review all documents needed for regulatory submission.
• Perform first time check of submission documents.
• Support the resolution of all issues related to the submission documentation
• Provide a guidance to the study team with regards to the submission documents
• Develop, mentor, manage and coach regulatory staff to progress their skills so that Comac Medical quality standards are maintained

What is required for the role?

• Graduate or postgraduate degree
• At least 3 years of experience in Regulatory activities with regards to the clinical research
• Working knowledge of current ICH/GCP guidelines, applicable regulations (including regional specific ones), and current industry practices.
• Excellent organizational, communication (verbal and written) and interpersonal skills.
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.
• Proficiency in English.
• Positive attitude and ability to interact with all levels of staff.
• Ability to work under pressure and to keep tight deadlines.
• Working knowledge of Word, Excel, and Power Point.

Why to join Comac Medical?

• Great team of knowledgeable, high-achieving and experienced professionals;
• International and diverse work atmosphere;
• Challenging projects in a different therapeutical area as well as in early phases;
• Opportunity to enrich professional skills and progress in career development;
• Competitive remuneration;
• Professional trainings;

Core strengths of Comac Medical

• Proven track record for quality and delivery;
• Established and trusted relationships with KOLs;
• Motivated, capable and dedicated team;
• Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

COMAC MEDICAL is a Full-service CRO/SMO providing a broad network of clinical research sites in the best healthcare institutions across Central and Eastern Europe. Due to our successful development we are looking for our new projects in Bulgaria highly motivated and responsible candidates for the position of: Senior Clinical Research Associate (III)

The person:

– Graduate or postgraduate degree

– At least 4 years as a Clinical Research Associate/Clinical Monitor

– Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.

– Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations.

– Excellent organizational, communication (verbal and written) and interpersonal skills.

– Positive attitude and ability to interact with all levels of staff.

– Proficiency in English

– Ability to work under pressure and to keep tight deadlines

– Working knowledge of Word, Excel, and Power Point.

The activities:

– Conducts feasibility studies, as requested

– Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

– Gains an in-depth understanding of the study protocol and related procedures

– Conducts site qualification visits

– Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out

– Customizes patient information sheets and consent forms, as required

– Participate, if requested, in the preparation of and review of study documentation e.g. draft protocols, draft CRFs;

– Participates in contracting process, if required

– Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

– Performs remote and on-site monitoring & oversight activities

– Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CTL/CMM/PL

– Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines

– Assists in audit preparations;

– Updates and maintains tracking logs, if required

– Performs project-specific documents translations, if required;

– Assists in the planning and execution of Investigator Meetings or other study related meetings;

– Assume additional responsibilities as directed by Project Manager.

– Human resource management

–       Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME)

The Company Offer:

– Work for successful international company, excellent career development opportunity in a perspective professional field;
– Competitive remuneration package;
– Additional benefits related to work performance;
– Work in a team of motivated and qualified professionals;
– Оpportunity for development and learning in the work process.

The Assigned Country: Bulgaria