Gilead
Life Sciences
ClinicalTrialsManager
“Clinical Trials Manager at Gilead. Skills: Clinical Trial Management, Study Logistics, Regulatory Compliance. Manage geographical region(s) of assigned clinical studies. Manage multiple components of larger studies”
What You'll Achieve.
Provide timely and high-quality clinical data; Support global registration and commercialization of Gilead’s products; Fulfil regulatory commitments; Fulfil safety obligations; Meet evidence needs for regulatory filings; Accomplish clinical study objectives; Ensure study execution remains on track
Industry & Context.
Proactively identifies potential operational challenges; Collaborates with other Clinical Operations’ colleagues to provide solutions
Ability to travel when needed
What They're Looking For.
Must Have
MA / MS / PharmD / PhD with 3+ years’ relevant clinical experience in life sciences, BA / BS / RN with 5+ years’ relevant clinical experience in life sciences, Minimum of 2 years of Post-Authorization Non-Interventional study management experience at international level, Experience in managing sites activities as study coordinator, Experience in oversight site activities as Clinical Research Associate (CRA), Experience in working with cross-functional stakeholders as Medical Affairs and Real Word Evidence/Epidemiologist teams, Demonstrated ability to be a fast learner, Demonstrated ability to be flexible and adaptable to change, Ability to manage any component of full cycle study management, Advanced knowledge of study management best practices and tools, Fully understands protocol requirements, Knowledge of Food & Drug Administration (FDA) regulations, Knowledge of European Medicines Agency (EMA) regulations, Knowledge of other applicable national regulations, Knowledge of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Knowledge of Good Clinical Practice (GCP) governing the conduct of clinical studies, In deep knowledge of Good Pharmacovigilance Practice (GVP), Knowledge of FDA RWE guidances, Familiar with standard medical / scientific terminology, Ability to communicate in a clear and concise manner, Ability to support a team-oriented, highly-matrixed environment, Ability to execute multiple tasks as assigned
Nice to Have
When needed, ability to travel
What You'll Do.
Manage geographical region(s) of assigned clinical studies
Manage multiple components of larger studies
Define study logistics
Oversee development of clinical study plans
Manage study timelines
Oversee/author study plans
Provide input into study protocols
Provide input into case report forms
Provide input into informed consents
Oversee study sites/region
Review routine regulatory documents
Lead preparation of safety reports
Lead preparation of interim study reports
Lead preparation of final study reports
Resolve data discrepancies
Identify potential operational challenges
Participate in initiatives / projects
Act as a Business Lead in initiatives / projects
Manage project meetings
Manage conference calls with CROs
Manage conference calls with other vendors
Manage conference calls with cross-functional teams
Contribute to SOP development
Participate in special projects
Develop tools and processes
Optimize project efficiencies
Optimize project effectiveness
Assist in training new colleagues
Assist in training less experienced colleagues
Ensure own work complies with established practices
Ensure own work complies with policies
Ensure own work complies with processes
Ensure own work complies with regulatory requirements
How You'll Work.
Team & Collaboration
Collaborates with other functions on study goals; Communicates cross-functionally to ensure project team goals are met; Works with cross-functional stakeholders; Supports a team-oriented environment; Supports a highly-matrixed environment
Communication Scope
Communicate in a clear and concise manner
Process & Methodology
Manage study timelines, Manage project meetings, Manage conference calls
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