Clinical Trial Manager - Foster City, United States - Leadstack Inc

Leadstack Inc

Verified Company

Foster City, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Job Details:

LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce.

As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Title:
Clinical Trial Manager
**Location: Foster City

Hybrid**
Duration: 6 months

PR:
$70/hr - $80/hr

Description:

FUNCTION:
Clinical Operations - Biomarker and Bioanalytical Operations

Clinical Operations is responsible for the worldwide execution of all Phase I
IV clinical trials across all client therapeutic areas.
Clinical Operations plays a key role in ensuring all client clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and highquality clinical data that supports global registration and commercialization of clinet products.
You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other crossfunctional 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 Gilead (GS) and Collaborative (CO) programs.
Participate in multiple Phase 14 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 daytoday 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 crossfunctional 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 crossfunctional 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 soluti