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Manager, Clinical Research

Covance 1/11/2019 8:10:49 AM
JOB ID: 21851 Category: Clinical Operations Entry Level
Maidenhead, United Kingdom



Job Overview

This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, and procedures, quality standards and adverse event reporting requirements internally and externally.

The CRM/CTL could be responsible for a particular study for several countries in a cluster.

Responsibilities include, but are not limited to:

* 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, quality standards and adverse event reporting requirements internally and externally.
* Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
* 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
* Country POC for programmatically outsourced trials for assigned protocols.
* Serves local business needs as applicable in his/her country(If delegated can sign contracts and manage budgets)
* 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.
* As a customer-facing role, this position will build business relationships and represent MSD with investigators
* Shares protocol-specific information and best practices across countries\clusters

Education / Qualifications


* Bachelor degree in Science (or comparable)


* Advanced degree, (e.g., Master degree, MD, PhD


Experience Requirements:


* 5-6 years of Experience in clinical research of which 3 as CRA

Position Type: Full-Time

Location: Maidenhead, UK - United Kingdom


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).