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Contract Associate Clinical Study Manager

Employer
Proclinical Staffing
Location
Liverpool, Merseyside, England
Salary
Up to GBP350 per day + Highly Competitive Salary
Start date
31 Mar 2023
Closing date
14 Apr 2023

Job Details

Proclinical are recruiting a Contract Associate Clinical Study Manager for a leading biotech organization. This role is on a contract basis and located in the UK.

Job Responsibility:

  • Study Start Up
  • Contribute to the development of study specific documentation, as delegated by the Study Manager
  • Contribute to the management of country and site feasibility assessment
  • Contribute to and support the management of site initiation including but not limited to documents relating to Regulatory and EC approval, Investigational Product release etc
  • Prepare site staff/CRO training and investigator meeting materials and present at investigator meetings as assigned
  • Ensure timely study entry and updates to ClinicalTrials.gov
  • Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor)
  • Provide administrative assistance with internal and external meetings including investigator meeting(s)
  • Facilitate Screening Authorization Forms tracking/sign off when applicable
  • Assist with IP Pack Release Form review QC checks
  • Manage various Clinical Operations document translations
  • Process documents for signature in DocuSign
  • Site management for delegated site(s)
  • Vendor Oversight and management ensuring expectations and deliverables are adhered to
  • Clinical Trial Insurance
  • Study Closeout
  • Other Responsibilities
  • Create/maintain essential document trackers
  • Provide continuous, filing, input to eTMF content list, and Conduct comprehensive TMF document review, as per TMF Plan
  • Assist with Clinical Operations internal filing of study documents in SharePoint/Teams and eTMF
  • Contribute to Clinical Operations risks identification and mitigations
  • Participate in "Lessons Learned" workshop(s) and check-ins

Skills and Requirements:

  • BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
  • 1-3 Years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO
  • Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)

If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 4400 639.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-MP1

#Clinical

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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