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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
Турция: Мениджър 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 Istanbul, Turkey for highly motivated and responsible candidates for the position of: Clinical Site Manager

Knowledge, skills & abilities:

– Graduate or postgraduate degree

– At least 3 years’ experience as Site Coordinator or Clinical research associate/Clinical Monitor

– 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 or lead the feasibility process, as directed

– Support the site team and Site coordinators with regards to subject pre-selection and recruitment as needed;

– Support the site team and Site Coordinators in subjects’ visits planning and preparation as needed;

– Complete Case Report Form;

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

– Support the maintenance of Investigator Site File as needed;

– Participate in and if required coordinate any trainings and meetings (incl. Investigator Meetings) related to a specific study;

– Collaborate with the site team and Site coordinators for any adverse events and safety information reporting and escalation as needed;

– Support Site Coordinators in logistic organization and coordination of study medication, other study supplies and biological samples

– Ensure timely site equipment maintenance and calibration

– Handle subject expenses reimbursement as requested;

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

 

Department Management

– Perform Investigator site qualification prior to signing any contractual agreements;

– Participate in and facilitate audits and inspections at the site.

 

Human resource management

– May conduct field training and assessment of Site Coordinators

– Perform internal QC of Site Coordinators;

 

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.

– Perform other duties as assigned by Leadership.

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

 

The Company Offer:

− Job-specific training;

− Work for a successful international company, excellent career development opportunity in a perspective professional field;

− Competitive and result orientated remuneration;

− Additional benefits related to work performance.

 

The Assigned Country: Istanbul, Turkey

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

Европа: Експерт писане на документи

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 Europe for highly motivated and responsible candidates for the position of: Medical Writer.

Duties and activities:
– Creation or review of Clinical Study Protocols (for early and late phase clinical trials, non-interventional studies, PASS etc.);
– Participation in creation of Clinical Development Program, as directed;
– 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.

The Person:
– 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 work under pressure and to keep tight deadlines;
– Working knowledge of Word, Excel, and Power Point.

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: This International assignment. Candidates from all over Europe are welcome

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.

Унгария: Сътрудник Клинични Изпитвания

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 Hungary highly motivated and responsible candidates for the position of: Clinical Research Associate.

Duties and activities:
– 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
– Participates & provides inputs on site selection activities as required
– Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
– Customize 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 Lead CRA/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.

The Person:
– Graduate or postgraduate degree
– At least 1 year and half 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.
– 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 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: Hungary

Турция: Главен Сътрудник Клинични Изпитвания

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 Turkey  highly motivated and responsible candidates for the position of: Senior Clinical Research Associate.

Duties and activities:
– 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
– Participates & provides inputs on site selection activities as required
– Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
– Customize 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 Lead CRA/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.

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.
– 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 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: Turkey

Турция:Координатор на клиничен сайт

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

The Profile:
− Supporting Principal Investigator in equipment and staff needs planning;
− Collection and transfer of site-related documents for initial submission package and ongoing submission package;
− Regular updates of essential documents;
− Assisting in preparation of any study related documents;
− Assisting in CRF completion, when applicable;
− Logistic support related to transfer of information and materials;
− Collaborate with the site team concerning patients pre-screening and recruitment
− Activities related to drug storage, total reconciliation and documents completion;
− Collaborate and facilitate monitor on-site or remote visit;
− Report the trial progress by writing reports and collecting trial-specific data, keeping correspondence, participating in project meetings and teleconferences;
− Financial accountability for patients’ travel expenses;
− First point of contact with CRA/ CRO.

The Person:
− University degree in Medical or Life Sciences is preferable;
− Experience in Clinical Trials activities is preferable;
− Excellent command of English – both written and spoken;
− Excellent computer literacy;
− Active driver;
− Very good attention to details, excellent analytical capabilities;
− Responsible, pro-active, well-organized and committed person, team player;
− Ability to work under pressure and to keep tight deadlines.

The Company Offer:
− Job-specific training;
− Work for a successful international company, excellent career development opportunity in a perspective professional field;
− Competitive and result orientated remuneration;
− Additional benefits related to work performance.

The Assigned Country and cities: Afyon, Тurkey and/or Kayseri, Turkey

ОТПРАВИЗАПИТВАНЕ