Title: Clinical Trials Manager - I

Location: Foster city, CA

Duration: 6+ months contract

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas. Clinical Operations play a key role in ensuring all

clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports

global registration and commercialization of products.

You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members. You will manage certain

components of clinical studies and act as a member of the study team. You will also manage biomarker and bioanalytical vendors. You will assist in the review of clinical study

protocols and other study documents, contribute to process development and/or participate in special projects. You may also participate in strategic initiatives.

EXAMPLE RESPONSIBILITIES:

• Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and

bioanalytical strategies in (GS) and Collaborative (CO) programs

• Participate in multiple Phase 1-4 clinical study teams

• Plans and coordinates all operational activities required 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.

• Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development