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Clinical Research Manager

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Company :
Eurofins USA Consumer Product Testing

Location :
Winston-Salem, North Carolina

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Description :
Job Description

Eurofins, CRL Cosmetics, Inc. is a clinical testing laboratory located in Winston-Salem, NC that specializes in evaluating the safety and performance of topical antiseptics, personal care products, and cosmetics.

ABOUT THE POSITION:
The Clinical Research Manager is responsible for overseeing all clinical testing projects by managing several cross-functional teams (SPF, Clinical, Subject recruitment) to successful execution of each study. The Clinical Research Manager provides the following competencies:

Strategic and operational leadership to subject recruiting and technical testing teams to ensure project milestones are delivered on time and in compliance with Good Clinical Practices guidelines, applicable SOPs, and study protocols. Interfaces with clients as needed.

* Controls the budget and spending.
* Overseeing Site adverse events reporting
* Experience in managing staff.
* Plays an active part in creating efficiencies across the lab through adoption of LEAN/efficiency processes.
* Works with upper management to develop a growth strategy for the site.

POSITION DUTIES:

Broad oversight of approximately 10-20 staff members

Be listed as PI (Principal Investigator) on clinic study protocol and reports

Responsible for overseeing data management and providing guidance on statistical interpretation of results, as appropriate.

Ensure that all relevant aspects of GCP compliance and audit readiness are maintained throughout study conduct.

Develop and oversee subject recruitment strategies.

Develop and maintain good working relationships with contracted study Investigators (Dermatologists).

Proactively manage and identify potential study issues and recommend/implement solutions to maintain study quality and meet project milestones.

Manage several direct reports and team members and perform performance evaluations as assigned.

Interact directly with customers and internal sales representatives via phone, email, and in-person.

Interact directly with clinical study subjects via phone, email, and in-person, as needed.

Review Standard Operating Procedures (SOPs) and maintain and improve lab documents and record keeping procedures.

Work with QA to assure study integrity, protocol and SOP compliance in all aspects of testing

Assist with sales, marketing, and outreach efforts as needed.

Interact with and provide detailed and accurate information to accounting personnel.

Maintain a safe, fast-paced, and positive laboratory environment.