The Medical Affairs Study Scientist oversees and coordinates with the Study Medical Lead (Clinical Research Physician, CRP, or Medical Affairs Disease Lead, MADL), and within the Study Team, all the clinical and scientific activities of assigned studies. This is in order to guarantee the quality and timeliness of study planning, implementation, execution and close-out. The Study Scientist is the key contact for study related clinical/scientific questions and issues.
Responsibilities include, but are not limited to:
1. Review and provide input to the protocol synopsis, and protocol, and develop the master Informed Consent Form, according to the Clinical Development Plan and as approved by the Hematology and Oncology Development Committee for Interventional Clinical Trials or by the Medical Affairs Independent Review Committee for Non-Interventional Post Authorisation Safety Studies (NI-PASS) and Non-Interventional Post Authorisation Efficacy Studies (NI-PAES) .
2. Review and provide clinical input to the Statistic Analysis Plan, Monitoring Plans, Risk Management Plan, Case Report Forms (CRFs), edit specifications/checks, CRF completion guidelines, Study Charters and relevant regulatory documents, as required.
3. Lead the development of the Clinical Data Review Plan (CDRP), collating input from all relevant functions, and lead meetings thereof.
4. Ensure that clinical study milestones are aligned from a clinical/scientific perspective and consistent with the clinical program or regulatory authority expectations for NI-PASS and NI-PAES.
5. Select countries, identify prospective sites and contribute to the selection of the final sites, in collaboration with the Medical Lead.
6. Address any clinical / scientific issues arising from regulatory authorities and ethics committees.
7. Participate in the selection and assessment of study vendors.
8. Identify membership and provide input into the charters of the Data Monitoring Committee (DMC), Steering Committee (SC) and other committees as required, in collaboration with the Medical Lead.
9. Participate and Present at external Investigator Meetings and at internal meetings.
10. Support the study team with scientific expertise at study site initiation and subsequent motivational visits, as required.
11. Perform ongoing resolution of issues arising from patient clinical management e.g. patient eligibility and study conduct.
12. Provide input into safety data reconciliation.
13. Review data in an ongoing manner, i.e., safety, primary efficacy variables (where applicable), laboratory data and coding issues. Identify trends and follow up on any clinical issues/ discrepancies to be addressed to the sites.
14. Participate as a key meeting contributor in the DMC, SC, Risk Management and any related meetings, as appropriate.
15. Review and provide input into Clinical Study Reports and relevant clinical sections of the Investigator Brochure, as required.
16. Review, provide input, and lead clinical update of annual IND report and Periodic Safety Update Reports (PSURS), as required
17. Act as Study Manager/Back Up Study Manager for Celgene Sponsored Studies (non-interventional or interventional) on occasions as needed.
Profound medical/scientific knowledge
Thorough knowledge of clinical research, including basic statistics, pharmacodynamics and pharmacokinetics
Ability to analyse and assimilate technical and scientific data and to apply knowledge
Thorough knowledge of GCP and ICH Guidelines
Good written and oral English language skills
Excellent communication skills
Excellent interpersonal skills.
Ability to function in a matrix organisation.
Excellent analytical and organisational skills.
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