FUNCTION: Clinical Operations - Biomarker and Bioanalytical Operations
Top 3 Required Skill Sets: sample management experience, strong microsoft skills, excellent communication skills
Top 3 Nice to Have Skill Sets: clinical operations/bioanalytical operations experience, laboratory (bench) experience
EXAMPLE RESPONSIBILITIES: • Leads or manage components of Phase I, II or III studies • Assists Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinates all interactions and deliverables from vendors. • May assist as operational contact for Gilead studies • Plans and coordinates all operational activities required with the collection, delivery and analysis of biological samples within a clinical trial • Manages study timelines, including documentation and communications • Serves as the point of contact with internal and external stakeholders for successful implementation of all biological sample analysis strategy in Gilead (GS) and Collaborative (CO) programs • Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams. • Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting. • Participates in the review and approval of main study and optional informed consents, and may review additional study specific informed consents • Contributes to SOP development and/or participates in special projects • Develops tools and processes that optimize project efficiencies and effectiveness. • Proactively identifies potential operational challenges and collaborates with key stakeholders to provide solutions to ensure study execution remains on track to projected budgets and timelines. • Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience • MA/ MS / PharmD / PhD with 2 + years' relevant clinical or related experience in life sciences. • BA / BS / RN with 4 +years' relevant clinical or related experience in life sciences. • Experience in managing the work of external vendors. • Meets all requirements for Clinical Trial Management Associate (CTMA) grade 25 position with demonstrable proficiency.
Knowledge & Other Requirements • Demonstrated ability to be a fast learner. • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. • Knowledge of full cycle clinical study management, from start-up to close-out, and has shown ability to effectively apply this knowledge to achieve targeted study outcomes. • Significant industry knowledge. • Complete knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools. • 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. • When needed, ability to travel.