Senior Studies Associate Pharmaceutical

Posted 08 July 2022
Salary Negotiable
LocationCambridge
DisciplineLife Science
ReferenceTR/055816_1657282369
Contact NameVictoria Armitstead

Job description

Orion Group Life Sciences have an exciting opportunity for a Senior Studies Investigator Associate for our Multinational Pharmaceutical client based in Cambridge on an initial 12-month contract.

Purpose

  • To facilitate and support the operational implementation of single country Investigator Sponsored Studies (ISS) and support country specific operational implementation of multi-country ISS from planning to close-out, in accordance with global ISS SOPs and other supporting documentation.
  • To facilitate country-specific operational implementation of Expanded Access requests per global EA SOP and supporting documents

Responsibilities:

  • Serve as operational point of contact to stakeholders and across functions for single country ISS (with regional GCPM NASCR Mgr/team guidance and oversight)
  • Support GCPM NASCR Mgr in facilitating operational ISS processes in accordance with global SOPs and other supporting documentation for multi-country ISS with contract in respective country of SAISS
  • Partner with stakeholders to ensure timely and appropriate support of single country ISS deliverables
  • Data entry and tracking in source systems
  • Maintain tracking of single country ISS proposals and protocols and facilitate review and approval process
  • Support set-up activities and provide sponsor support according to the to SOPs for single country ISS's
  • Liaise with Sponsor, Medical POC and internal budget holder to ensure good financial governance of single country ISSs
  • Serve as operational point of contact to stakeholders and across functions for country-specific EA requests (with regional GCPM NASCR Mgr/team guidance and oversight)
  • Assist the GCPM NASCR Manager/Senior
    Manager/Director in support of NASCR activities including process improvement and issue resolution

Basic Qualifications

  • Bachelor's degree & 2 years of directly related experience in life sciences or medically related field
  • Experience in biopharmaceutical clinical research or clinical operations experience (experience obtained working on working on investigator-sponsored, industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company)

Knowledge

  • Ability to understand technical, scientific and medical information
  • Working knowledge of ICH Good Clinical Practice (GCP), and applicable international regulations and guidelines
  • Understanding of drug development process and concepts of clinical research
  • Experience with regulatory approval processes
  • Experience in interactions with outside vendors, e.g. CROs and tertiary depots
  • Experience with administration of budgets, contracts and payment

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.