Clinical Trial Manager overseeing clinical trials managing operations and compliance in Brazil at IQVIA. Ensuring adherence to protocols and managing country - specific requirements.
About the role
- Senior Director, Clinical Scientist leading the design and execution of clinical studies at Summit Therapeutics. Collaborating with multiple teams to ensure successful enrollment and data interpretation.
Responsibilities
- Leads study design and amendments in collaboration with internal and external scientific stakeholders
- Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
- Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs
- Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders
- Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
- Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan, etc.)
- Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events
- Leads the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
- Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
- Coordinates submissions to scientific meetings and/or other appropriate venues or groups
- Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
- Train colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
- Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
- Supervise other clinical scientists in conduct of other studies
- All other duties as assigned
Requirements
- MS (or equivalent) preferred or BA with minimum 10 years industry experience required
- PhD, PharmD, or MD preferred
- Minimum of 5 years experience in conducting / supporting oncology/hematology clinical studies
- Excellent written and verbal communication skills
- Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data
Benefits
- bonus
- stock
- benefits
Job title
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