Trial Physician - Clinical Trials - Pharmacovigilance

TRIAL PHYSICIAN/BEERSE, BELGIUM/2 MONTHS CONTRACT/55 TO 92 EUR (PER HOUR)

- Contribute to the design of the trial through creation of the Trial Information Form (TIF).
- Contribute to the development of the Clinical Trial Protocol and its review within the specified timelines.
- Contribute to the development and review of the trial specific risk benefit document, as applicable
- Contribute to investigator meeting presentations/site initiation visits (SIV) as applicable
- Review the Trial specific Master Informed Consent Form within the specified timelines.
- Contribute to responses to trial related questions from IECs/IRBs
- Review the Statistical Analysis plan (SAP) within the specified timelines.
- Review the Data Safety Monitoring Board (DSMB) protocol.
- Review and approve protocol specific PV criteria list
- Developincluding periodic completion of the Safety Management Plan for individual trials.
- Assist in the determination whether new safety information requires an Amendment to the CTP and/or ICF
- Review and approval of AE coding and concomitant medication lists.
- Review AEs of Special Interest
- Assess Protocol Violations
- Contribute to Trial Team Meeting on an agenda driven basis
- Review SAEs in Real Time and provide input of the assessment as needed
- Contribute to the development and review of protocol amendments
- Review trial specific ICF for updates based on CTP amendment, IB amendment or updated IB
- Review and approval of AE coding and concomitant medication lists.
- Review PV listings
- Assist in preparation of the safety part of Top Line Results presentation
- Review narratives
- Assist in creation and review of Clinical Research Report and approve if applicable
- Assist in ADR review and adjudication
- Assist in labeling process as applicable
- Contribute to presentation of trial results as needed
- Report regularly and work closely with Global Medical Leader
- Interact with clinicians/experts (eg Advisory boards) as necessary
- Act as a support to and resource for Medical Affairs.
- Assist in the creation of regulatory/submission documents (eg clinical summaries, clinical overviews, ASR, IND update)
- Assist in creation of Investigator Brochure.
- Assist in writing/review of abstracts/manuscripts.
- Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company's effort towards continuous quality improvement.
- Participation and cooperation in Clinical Team and in other Cross-functional teams, ad hoc.

REQUIRED CERTIFICATIONS/REGULAR TRAINING (EG IATA, GCP, CAP/CLIA, IAP)

- Employee must follow the schedule for mandatory trainings required by Janssen/Johnsonincluding, but not limited to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and regulations, as well as other Standard Operating Procedures (SOPs)
- It is expected that the employee will keep up-to-date with general medical topics and topics relevant to the therapeutic area

EDUCATION AND EXPERIENCE

- University degree - medical;
- Preferably experience in drug development (eg Project Management, Pharmacovigilance, Medical Affairs, Pharmacokinetics), and/or
- Preferably experience in clinical development (eg medical dept. or operations);
- Experience in functioning in team structure

NON TECHNICAL SKILLS AND ADDITIONAL DETAILS

- Good communication skills;
- Ability to effectively work as part of a team.
- Conflict handling skills;
- Good knowledge of English (both written and spoken).
- Presentation skills
- Organizational skills
- Knowledge
- Therapeutic domain preferred, but not required at entry
- Working knowledge of guidelines and applicable SOPs regarding the development of new chemical entities and the conduct and medical supervision of clinical trials, preferred, but not required at entry
- Computer literacy.

THE CLIENT

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

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