Senior Associate, Investigator Sponsored Studies

1 week ago

Cambridge, United Kingdom CK GROUP Full time

CK Group are recruiting for a Senior Associate, Investigator Sponsored Studies (ISS) to join a biopharmaceutical company, who are based in Cambridge on a contract basis for 12 months.
**Rates**:
Hourly: £26.00 PAYE or £35.00 Umbrella
**Company**:
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human geneticsto unravel the complexities of disease and understand the fundamentals of human biology.
**Location**:
The role is a hybrid working role, with travel into the office required occasionally in Cambridge.
Senior Associate, ISS
- 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 andother 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
**Experience required**:

- Master’s degree (preferred) or Bachelor’s degree & 2 years of directly related experience
- 5 years work experience in life sciences or medically related field, including 2 years of biopharmaceutical clinical research or clinical operations experienc
- 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

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54019 in all correspondence.

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