Expected to be the contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional team.
- Participate in the Clinical Development planning for assigned compounds in specific disease areas.
- Contact Key Opinion Leaders and perform/participate in advisory board meetings, in collaboration with the Clinical Research Physician (CRP)
- Support the study team with scientific expertise at study site initiation and subsequent motivational visits, as required.
- Develop the clinical scientific section of study-specific guidelines.
- Participate in document template design and SOP writing.
- Participate in the outreach for medical and regulatory advice Address any clinical / scientific issues arising from regulatory authorities and ethics committees.
- Ensure that clinical study milestones are aligned from a clinical / scientific perspective and consistent with the clinical program.
- Identify membership and provide input into the charters of the Data Monitoring Committee (DMC), Steering Committee (SC) and other committees as required.
- 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.
- Participate and Present at external Investigator Meetings and at internal and external meetings.
- Perform ongoing resolution of issues arising from patient clinical management e.g. patient eligibility and study conduct.
- Perform analysis of study data in order to develop a deep scientific understanding of our drug candidates.
- Provide input into safety data reconciliation.
- Participate as a key meeting contributor in the DMC, SC, Clinical Data Review Plan, Risk Management and any related meetings, as appropriate.
- Review and provide input into Clinical Study Reports and relevant clinical sections of the Investigator Brochure, as required.
- Profound medical/scientific knowledge, especially in the fields of immunology, neurology and/or hematology
- Knowledge of clinical research, including basic statistics, pharmacodynamics and pharmacokinetics;
- Ability to analyze and assimilate technical and scientific data and to apply knowledge;
- Knowledge of GCP and ICH Guidelines;
- Good written and oral English language skills;
- Excellent communication skills;
- Excellent interpersonal skills;
- Detail-oriented and well-organized;
- Relevant advanced scientific or medical degree (e.g. PhD, PD);
- Experience in clinical research development or equivalent is a plus.
For more information please contact me at: +31 (0)20 20 44 502 or firstname.lastname@example.org.