- University degree - MD
- Preferably experience in drug/clinical development and/or registry, surveillance studies (e.g. Project Management, Pharmacovigilance, Medical Affairs, RWE, Clinical Pharmacology, study operations)
- Post-marketing surveillance studies
- Experience in functioning in team structure
- Good communication and presentation skills
- Project management
- Ability to effectively work as part of a team.
- Conflict handling
- Good knowledge of English (both written and spoken)
- Therapeutic domain (Ophthalmology) preferred, but not required
- Working knowledge of guidelines and applicable SOPs regarding the development of new chemical entities and the conduct and medical supervision of clinical trials/registries preferred
- Computer literacy
- Contribute to Study 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 study specific ICF for updates based on CTP amendment, 18 amendment or updated 18
- Contribute to the design of the study through creation of the Protocol Elements Document (PED)
- 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/lRBs
- Review the Statistical Analysis plan (SAP) within the specified timelines.
- Review the Data Safety Monitoring Board (DSMB)/ Data Monitoring Committee (DMC) charter in consultation with a physician
- Review and approve protocol specific protocol deviation (PD) criteria list.
- Develop & agree on the Safety Management Plan (frequency, format and content of reports provided) in consultation with a physician
- Input in SOW for central lab, central ECG and other vendors as applicable in consultation with a physician
- Review of (e)CRF and other data collection tools
- Give input in site selection
- Provide trial/compound specific training to monitors
- Answer trial related medical questions and interact with investigators/sites, CROs, etc.
- Review medical aspects of screening and ascertain suitability of subjects as needed
- Review of Data and Safety Monitoring Board (DSMB) reports as applicable.
- Perform medical review and safety analysis of clinical trial subjects; including 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
- 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 (e.g. Advisory boards) as necessary
- Act as a support to and resource for Global Medical Affairs Team
- Assist in the creation of regulatory/submission documents (e.g. 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 Core Study Team and in other Cross-functional teams, ad hoc.
- Employee must follow the schedule for mandatory trainings required by client for this position, within the specified time frame; including, 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/scientific topics and topics relevant to the therapeutic area
- ERIS (Regulatory Documents Database)
- Intralinks (SAE reporting)
- Lab database
- eDC (if applicable)
- Other trainings as needed
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Description
Study Responsible Physician
Ongoing Contract
Part Time Hours: 10-20 hours a week
Remote
Education and Experience:
Skills:
Knowledge:
Overview:
Pre-study activities:
During study activities:
Post-study activities:
Other responsibilities:
Required Certifications/Regular Training (e.g. IATA, GCP, CAP/CL/A , /AP)
Tasks/Activities to be Qualified or trained for (e.g. tasks, qualification)
