Clinical Trial Manager

3 weeks ago

Foster City, United States eTeam Full time

Clinical Operations – Biomarker and Bioanalytical Operations

Onsite In Foster City- Hybrid

Pay Rate: $78 - $88 per hour on W2

Duration: 6 month Contract with possible extension

POSITION OVERVIEW:

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

Client's 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 Client's 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.


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 Client's (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.

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.

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