Clinical Team Lead
Covance
Taiwan
24天前

Job Overview

We are hiring Clinical Team Lead in Taiwan andbased at our pharmaceutical client sitesfor project management.

Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).

Responsible for project management of the assigned studies : pro-actively plans, drives and tracks execution and performance of deliverables / timelines / results to meet country commitments from feasibility and site selection, recruitment, execution and close out.

Accountable for performance for assigned protocols in a country in compliance with ICH / GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.

o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and / or functional vendor and internal management as needed.

o Performs Quality control visits as required

Leads local study teams to high performance : trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration

Responsible for creating and executing a local risk management plan for assigned studies

Ensures compliance with CTMS, eTMF and other key systems in assigned studies

Escalates as needed different challenges and issues to TA Head / CRD / CQM and or CTT (as appropriate)

Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies

Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his / her studies.

GHH to be consulted as needed.

Shares protocol-specific information and best practices across countries clusters

Education / Qualifications

B.A. / B.S. preferred with strong emphasis in science and / or biology

Experience

10 years of experience in clinical research including 3 years as CRA, 2 years as project management

Job Number 2018-21418

Job Category Clinical Operations

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority / Female / Individual with Disability / Veteran / Sexual Orientation / Gender Identity).

Your confidentiality and privacy are important to us.

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