Clinical Trial Manager

Remote Clinical Trial Manager – Perm. - $100,000 - $150,000
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Clinical Trial Manager

Role Description

• Contribute to study documents development, such as protocol, ICF, CRF and other essential documents
• Contribute to study operational plans development, such as study management plan, communication plan, monitoring guidelines, laboratory manual…
• Coordinate investigational sites contracts implementation
• Track and follow budgets and invoicing for investigational sites
• Coordinate with Chemistry and Manufacturing Control (CMC) team for IMP management
• Coordinate with support functions such as legal and finances

Coordinate vendors, in particular by:
• Following planning and respect of timelines
• Following action plan(s)
• Checking compliance to commitments
• Monitoring the work performed and quality of deliverables
• Following corrective and preventive actions (CAPA) when required
• Contribute to study oversight:
• Implement and maintain study tracking and reporting tools
• Monitor Key Performance Indicators and Key Quality Indicators
• Perform co-monitoring visits at investigational sites
• Perform quality controls of monitoring visits reports
• Perform quality controls of the eCRF
• Contribute to internal data reviews
• Ensure compliance to applicable procedures, GCP-ICH and all other applicable regulations
• Follow corrective and preventive actions (CAPA) plan, where required
• Inform, escalate issues as appropriate
• Ensure administrative and logistical follow-up of the trial:
• Global control of study treatments: availability at site, stocks, return, expiration date, relabelling …
• Following of biological samples collection as well as other central activities monitoring (ECG, PK …)
• Manage study documentation in-house and with vendors throughout the duration of the study, from the TMF set-up to final archiving
• Perform monitoring and management of investigational sites, where required
• Contribute to Independent Committee(s)/Board(s) management
• Contribute to Quality System development/improvement

Skills & Requirements

• Strong knowledge of applicable standards such as clinical trial regulations and guidelines, GCP-ICH guidelines
• Contribute to study documents development, such as protocol, ICF, CRF and other essential documents
• Bachelors degree in Health or Life Sciences
• Specific training to Clinical Research
• At least 2 years-experience in clinical research operations in a CRO or in a pharmaceutical company.
• Must be Located in NY/NJ/PA (potential for MA candidates as well)
• Job is fully remote but candidate must be willing to travel once a quarter on-site and to Paris.

Educational Requirements:
• Bachelors degree in Health or Life Sciences
• Specific training to Clinical Research
• At least 2 years-experience in clinical research operations in a CRO or in a pharmaceutical company.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1139408

Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Remote
Specialism
Pharma
Pay
100,000 - 150,000
Ref:
1139408