Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and bioanalytical strategies in Gilead (GS) and Collaborative (CO) programs.
Participate in multiple Phase 1-4 clinical study teams.
Plans and coordinates all operational activities r.equired with the collection, delivery and analysis of biological specimens within a clinical trial
Provides sample management expertise to the Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPST).
Accountable for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
Primary interface for operational activities between the SMT and laboratory vendors; Provides the day-to-day operational management of vendors to ensure delivery data against contracted scope of work.
Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility.
Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., Biomarker Sciences, Vendor Outsourcing, Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker strategy.
Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure biomarker strategy remains on track.
Organizes and leads Biomarker and Bioanalytical operational meetings with study functional groups or vendors.
Maintains internal Biomarker and Bioanalytical Operations databases and document repositories.
Review of relevant documents including protocols, informed consents, and relevant study documents.
Must be able to understand, interpret and explain protocol requirements to others.
Assists in determining the activities to support a project’s priorities within functional area.
Contributes to development of RFPs and participates in selection of CROs/vendors.
Able to examine functional issues from an organizational perspective.
May contribute or participate in special projects.
Develops tools and processes that optimize project efficiencies and effectiveness.
May contribute to development of abstracts, presentations and manuscripts.
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
Must have a general, functional expertise to support Process development and implementation.
Provides knowledge and expertise on country specific regulations.
Participates in and manages project meetings and conference calls with vendors and cross-functional teams.
Develops tools and processes that optimize project efficiencies and effectiveness.
Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
May be required to present at internal or external meetings (i.e., investigator meetings).
Leads or otherwise assists in the preparation of interim and final study reports, including resolving any data discrepancies when biomarker data is needed for primary, secondary or support.
Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, 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
PharmD / PhD with 2+ years’ relevant clinical or related experience in life sciences.
MA / MS with 3+ years’ relevant clinical or related experience in life sciences.
BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences.
Knowledge & Other Requirements
Ability to manage any component of full cycle study management, from start-up to close-out.
Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
Thorough knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
Familiar with standard medical / scientific terminology.
Experience managing the work of external vendors.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Research, Analyst, and Information Technology
Industries
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