Summary of role description:

Responsibilities

• Serve as a member of representatives for Clinical Science on the molecule(s), study management team, and other molecule sub-teams as needed.
• Be responsible for the conduct of ongoing data reviews and medical monitoring.
• Serves as the point of contact internally for any clinical data questions about the molecule(s).
• Support the Clinical Science Lead for the content and completion of clinical trial documentation, e.g., protocol and amendments, investigator brochures (IB), informed consent form (ICF), and case report forms (CRFs).
• Work in collaboration with others on the study management team to ensure the Trial Master File (TMF) remains up to date, as well as in compliance with the overall study data quality plan.
• Be responsible for patient profile review, other data review (PD listing, Clinical Narratives etc.).
• Act as a participant in study start-up, study data base lock, data cleaning, study results interpretation, and study close-out.
• Participate and present, as needed, during interactions with investigator, study site visits, site training, and health authority inspections as a clinical science representative.
• Participate in developing data for scientific/clinical abstracts, posters, conference presentations, and manuscripts.
• Remain current and knowledgeable about both internal and external developments (e.g. key scientific publications/presentations, current clinical trial design considerations, disease-specific clinical trial outcomes, regulatory guidance that are relevant to the molecule(s) and disease area.

Requirements

• M.Sc. or Ph.D., required, with at least 5 years of clinical or research experience.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Demonstrated ability to perform effectively in a multi-disciplinary environment.
• Excellent communication skills (oral and written) and organizational skills.
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Demonstrated ability as a data Science expert in a complex matrix environment