Study Responsible Physician

1 month ago

OR United States Medasource Full time

Study Responsible Physician

Ongoing Contract

Part Time Hours: 10-20 hours a week

Remote


Education and Experience:

  • 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

Skills:

  • 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)

Knowledge:

  • 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


Overview:

  • 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


Pre-study activities:

  • 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


During study activities:

  • 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


Post-study activities:

  • 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

Other responsibilities:

  • 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.

Required Certifications/Regular Training (e.g. IATA, GCP, CAP/CL/A , /AP)

  • 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

Tasks/Activities to be Qualified or trained for (e.g. tasks, qualification)

  • ERIS (Regulatory Documents Database)
  • Intralinks (SAE reporting)
  • Lab database
  • eDC (if applicable)
  • Other trainings as needed

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