Study Management Associate - 6-12 months

Job Ref: J28226
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 29 August 2018
  • Cambridge, Cambridgeshire, England, UK
  • Competitive
    ANNUM
  • Arnaud Heroult
  • 0203 096 4712

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Study Management Associate (Clinical Trial Coordinator, CTC) - Early phase - 6-12 months - global Pharma - Office-based - Cambridge, UK

2 positions

6-12 months contract

Generous daily rate

Exciting Brand portfolio

One of my main pharmaceutical strategic partner is now seeking a Study Management Specialist in Early-phase studies.

The Study Management Associate is accountable for assisting Associate Directors Study Management and Study Management Leads fulfil their accountabilities through coordinating activities that ensure quality, consistency, and integration of study data and clinical trial processes and providing administrative support.

The exact accountabilities will differ depending on the exact nature of the clinical programme so a high degree of flexibility is required.

Responsibilities:

  • Contribute to the development of study documents as appropriate as well as any updates/amendments to those documents
  • Lead the preparation of country specific agreements (SMA), confidentiality agreements, clinical trial applications and other applicable country documents
  • Contribute to review of new/amended/unique SOPs and guidance documents
  • Ensure the supply of study materials and Investigational product by liaising with Investigational Product Supply or external service providers as appropriate
  • Support the study delivery team in the implementation of audits and regulatory inspections
  • Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the Associate Director Study Management
  • Interface with Investigators, third party vendors, Marketing Companies and internal staff to support effective delivery of a study and its regulatory documents through finalization of the protocol through to the Clinical Study Report (CSR) and administrative appendices
  • Maintain and close the TMF, ensuring continual inspection readiness
  • Initiate and maintain production of study documents, ensuring template and version compliance
  • Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and interface with data management representatives and sites to facilitate the delivery of study data
  • Prepare presentation material for meetings, newsletters and web-sites

Requirements:

  • University degree in related discipline, preferably in medical or biological science, or discipline associated with Clinical Research
  • Deep understanding of the drug development process, study management and data management
  • Excellent knowledge of ICH-GCP and basic knowledge of GMP/GDP
  • Fluent in written and spoken English
  • Experience of working with and delivering through strategic partners and 3rd party vendors
  • Good communication, negotiation, collaboration and interpersonal skills

About SRG:

SRG is the market leading supplier of Clinical and Drug development recruitment services to the Life Sciences industries. By putting people at the heart of what we do we are the catalyst that connects the best talent with organisations in the pursuit of 'Creating Tomorrow's World'& helping patients world-wide.

HOW TO APPLY?

For an immediate consideration please press 'apply' now, alternatively contact Arnaud Heroult on +44 (0)203 096 4712 and get more information about the role.

Our team at SRG Clinical also cover roles in Biometrics, Medical Affairs, Clinical Operations, Medical Information, Pharmacovigilance and Regulatory affairs so do not hesitate to call me at +44 (0)203 096 4712.

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We find that good people know good people. So when you recommend a friend to SRG and we place them in a contract or permanent job, you could earn a bonus of up to £1,000 of Red Letter Days vouchers as a thank you.

https://www.srg.co.uk/en/job-seekers/referral

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
28/09/2018 10:49:26
GBP 0.00 0.00.