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Кариери
В 23-тата година от създаването си, Комак Медикал е най-голямата българска компания в сферата на клиничните изпитвания, със стабилен растеж и отлична репутация във фармацевтичната индустрия.
Кратък преглед:

С повече от 300 служители по целия свят, ние в Комак Медикал се стремим да създаваме удовлетворяваща работна среда, която подкрепя сътрудничеството, творчеството и професионалното изпълнение на поставените задачи.

Ние вярваме, че наетите от нас професионалисти са най-ценният актив на една компания. За това предлагаме на своите екипи възможности за изграждане на многостранна експертиза чрез работа върху различни проекти. В допълнение за стимулирането им, сме разработили план за социални придобивки и политики, който включва предоставяне на средства за социални нужди, стипендии за образование, допълнително здравно осигуряване и различни дейности по сплотяване на екипите.

 

В Комак Медикал наемаме едни от най-добрите и способните служители на всички експертни нива, които да се присъединят към изследователските ни усилия в целия свят.

Ако искате да станете част от нашият екип и да допринесете с опита си за развитието на компанията, или пък се интересувате от студентска практика в структурите на Комак Медикал, свържете се с нас на hr@comac-medical.com

Последни оферти за работа
Словения: Координатор на клиничен Център

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 Slovenia for highly motivated and responsible candidates for the position of: Clinical Site Coordinator

Knowledge, skills & abilities:

– Graduate or postgraduate degree

– At least 1 year’ experience in the field of clinical research

– Working knowledge of current ICH/GCP guidelines, applicable regulations (including country specific ones), and current industry practices.

– 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 work under pressure and to keep tight deadlines.

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

 

Responsibilities:

Project responsibilities:

– Support all types of feasibility inquiries at the respective site(s);

– Conduct all types of feasibility inquiries at the respective site(s);

– Support the site team with regards to subject pre-selection and recruitment;

– Support the site team in subjects’ visits planning and preparation

– Prepare and organize source documentation;

– Complete Case Report Form;

– Collaborate and facilitate monitor on-site or remote visit;

– Maintain Investigator Site File;

– Participate in and if required 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;

– Perform additional study specific procedures, as delegated by the PI

– Support project team in the collection of site-specific documents

– Support the site team in audit/inspection preparation, as needed

 

General responsibilities:

– Represent Comac Medical in a professional manner.

– Perform other duties as assigned by Leadership.

– Follow strictly the applicable for the position company policies and procedures.

 

The Assigned Country: Slovenia

Сърбия: Координатор Клиничен Център

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 Serbia for highly motivated and responsible candidates for the position of: Clinical Site Coordinator.

Knowledge, skills & abilities:

– Graduate or postgraduate degree

– At least 1 year’ experience in the field of clinical research

– Working knowledge of current ICH/GCP guidelines, applicable regulations (including country specific ones), and current industry practices.

– 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 work under pressure and to keep tight deadlines.

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

 

Responsibilities:

 

Project responsibilities:

– Support all types of feasibility inquiries at the respective site(s);

– Conduct all types of feasibility inquiries at the respective site(s);

– Support the site team with regards to subject pre-selection and recruitment;

– Support the site team in subjects’ visits planning and preparation

– Prepare and organize source documentation;

– Complete Case Report Form;

– Collaborate and facilitate monitor on-site or remote visit;

– Maintain Investigator Site File;

– Participate in and if required 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;

– Perform additional study specific procedures, as delegated by the PI

– Support project team in the collection of site-specific documents

– Support the site team in audit/inspection preparation, as needed

 

General responsibilities:

– Represent Comac Medical in a professional manner.

– Perform other duties as assigned by Leadership.

– Follow strictly the applicable for the position company policies and procedures.

 

Country addsigned: Serbia

Мениджър Централна Лаборатория

Knowledge, skills & abilities:

– Graduate or postgraduate degree in Chemistry, Biology or another relevant scientific field

– At least 4 years in performing analysis in laboratory with the same scope of activities

– At least 2 years’ experience providing work direction and leadership to people and teams which includes employees’ development (mentoring), performance management and conflict resolution

– Working knowledge of current ICH/GCP guidelines, applicable regulations (including country specific ones), and current industry practices.

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

– Ability to balance needs of the organization with needs of staff.

– Ability to manage multiple priorities within the department and across staff.

– Ability to reason independently for the purpose of assessing and recommending specific solutions in bioanalytical 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 MS Office and specialized software.

 

Responsibilities:

Central laboratory activities

– Enforce implementation of current industry practices with regards to the central laboratory services

– Generate action plans and provide developmental/strategic oversight to optimize central laboratory services, with a focus on high quality delivery of individual/team/departmental goals.

– Work with Quality group to continually improve and enhance laboratory team expectations and procedures to promote quality, consistency and efficiency in execution

– Assist Quality group with review and revision of departmental SOPs, working practices, and policies.

– Support Quality group with regards to the audit and inspection preparation

– Present monthly reports to the company executive board.

– Participate for regular management meetings

– Create annual department report.

 

Human resource management

– Allocate the resources within the central laboratory team

– Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project. Update tracking systems.

– Develop, mentor, manage and coach central laboratory staff to progress their skills so that Comac Medical quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.

– Assist central laboratory team members with project specific issues.

– Maintain metrics pertinent to central laboratory resource oversight

– Manage central laboratory staff in accordance with Comac Medical values and policies.

– Assist with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.

– Promote company reputation across the employees.

 

Project Duties/Responsibilities:

– Prepares/reviews lab manuals and all attendant documentation.

– Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.

– Assist CFD/Project Leader with determination of project task lists related to the central lab activities

– Assist CFD with regards to central laboratory budget preparation

– Manage logistics of study samples and laboratory supplies

– Handle vendor management with regards to samples shipments.

 

Business Development Duties/Responsibilities:

– Participate in the development of the central laboratory portion of client proposals.

– Participate in marketing activities, client presentations, and proposal development.

 

General responsibilities:

– Represent Comac Medical in a professional manner.

– Maintain awareness of company policies so as to effectively represent the company perspective to the staff.

– Collaborate with other departments and/or functional groups to ensure consistency of processes.

– Perform other duties as assigned by Leadership.

– Follow strictly the applicable for the position company policies and procedures.

Юрисконсулт

Knowledge, skills & abilities:

– Master degree in Law

– Completed six months’ probation and successfully passed theoretical and practical examination, as required by the State;

– 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 work under pressure and to keep tight deadlines.

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

 

Responsibilities:

Legal affairs activities

– Review, draft and negotiate a broad range of contracts

– Ensure that contracts are in compliance with legal, regulatory and organization policies.

– Liaise with Human Resources on all issues of the law related to the organization’s human capital.

– Perform interpretation of legal acts and provide inputs

– Advise and represent the organization on legal issues

– Support company employees with regards to legal issues

– Support quality group in preparation of internal SOPs and contract templates, as needed

 

General responsibilities:

– Represent Comac Medical in a professional manner.

– Perform other duties as assigned by Leadership

– Follow strictly the applicable for the position company policies and procedures.

 

Специалист Логистика

Knowledge, skills & abilities:

– Higher education in Life sciences, Logistics, or another relevant field

– Knowledge of clinical research process.

– Working knowledge of current ICH/GCP guidelines and applicable regulations (including country specific ones)

– 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 MS Office.

 

Responsibilities:

Project Duties/Responsibilities:

– Support the preparation lab manuals and all attendant documentation.

– Manage logistics of study samples.

– Support the vendor management with regards to samples shipments.

– Maintain study specific clinical kits building.

– Monitor kits and project supplies inventory.

– Insures proper packing and labeling of study laboratory supplies.

– Support Quality Group in preparation of audits, as directed

 

General responsibilities:

– Represent Comac Medical in a professional manner.

– Collaborate with other departments and/or functional groups to ensure consistency of project processes.

– Perform other duties as assigned by Leadership.

– Follow strictly the applicable for the position company policies and procedures.

България: Специалист Лекарствена Безопасност

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 highly motivated and responsible candidates for the position of:

Pharmacovigilance Specialist (PV Specialist)

The Profile:
– Operate as an EU QPPV (Qualified Person Responsible for Pharmacovigilance) for MAHs (Marketing Authorization Holders) and Local QPPV
– Ensure the uniform and timely processing of expedited reports from clinical trials or post-marketing in accordance with SOPs and worldwide regulatory authority expectations;
– Ensure compliance with health authority regulations in all aspects of PV case processing and reporting;
– Collect and maintain database with PV regulations and requirements for Comac Medical countries of operation;
– Ensure valid SAE cases are completely and accurately data-entered into pharmacovigilance/ safety database;
– Oversee receipt, confirmation, and processing of clinical study serious adverse events (SAE) reports from multiple countries;
– Ensure all safety reports are evaluated, assessed and completed;
– Write or contribute to preparation of safety documentation for clinical trials (DSURs, Safety Management Plan, safety data line-listings etc.) and PV documentation for post-marketing (PSUR, PBRERs, Risk Management Plans etc.);
– Contribute to the development or maintenance of a Pharmacovigilance System Master Files for clients;
– Assist with pharmacovigilance processes, preparation of SOPs, product safety reviews and literature reviews, if required;
– GVP module I (I.C.1.3. Role of the qualified person responsible for pharmacovigilance in the EU;
– VOLUME 9A – Guidelines on Pharmacovigilance for Medicinal Products for Human Use (1.2.1 The Role and Responsibilities of the Qualified Person Responsible for Pharmacovigilance;
– Monitor and assess Drug Safety and benefit-risk profile from EU perspective for different therapeutic areas;
– Maintain project-specific safety database/ adverse event tracking systems;
– 24h/7day contact for reporting safety data;
– Execute routine quality review of SAE reports and other safety reports for other members;
– Triage events for expectedness and reportability along with the CRO;
– Liaise with clinical operations, regulatory affairs and data management regarding safety data collection and data reconciliation;
– Perform quality check of clinical trial documentation prior to EC and RA submission as per the local requirements and SOP in close collaboration with the study team;
– Assist in resolving issues related to submission process and requirements;

The Person:
− University degree in Medicine or Life Science;
− 4 years experience on a similar position;
− Regulatory experience will be considered as advantage;
− Responsible, pro-active, well-organized, team player;
− Good command of spoken and written English;
− Very good computer literacy;
− Willingness to expand his/ her professional expertise.
− Very good attention to details, excellent analytical capabilities.
The Company Offer:
− Job-specific training;
− Work for successful international company, excellent career development opportunity in a perspective professional field;
− Very competitive remuneration package;
− Additional benefits related to work performance.

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;
– Opportunity for development and learning in the work process

The Assigned Country: Bulgaria

If you are interested in such an opportunity please send your CV and a cover letter in English describing why your experience and skills make you a good candidate for this position.

България: Сътрудник Клинични Изпитвания (III)

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

България: Сътрудник Клинични Изпитвания (I и II)

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: Clinical Research Associate (CRA I and II)

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

ОТПРАВИЗАПИТВАНЕ