Senior Associate, Clinical Operations
Russell Oakley at CK Clinical is recruiting for a Senior Associate within Clinical Operations to join a leading Biotechnology company based in Cambridgeshire, on a full time, temporary basis for 12 months. This role will involve supporting the Clinical Operations Manager with overseeing operational activities related to planning, executing, and reporting of company sponsored clinical trials.
As a Senior Associate, Clinical Operations, you will have the following responsibilities:
- Contributing to site selection in consultation with Medical colleagues, Development Operations Manager (DOM) and Clinical Operations Manager (COM)
- Working with local study teams (COM, Clinical Trail Associates, Senior Contract & Budget Associate, Global Regulatory) to coordinate Ethic Committee/regulatory submission activities, meet operational milestones and manage day-to-day operations of study
- Supporting delivery of study-specific training to Clinical Research Associate
- Reviewing Monitoring Visit Reports, as applicable, and developing action plans for issues relating to quality, data flow and other study related risks
- Communicating study progress and escalating issues to COM/DOM, Global Study Management, Clinical Trial Oversight Manager and other key stakeholders, as required
- Engaging with local medical team (Medical Director, Regional Medical Liaisons) to support priority studies
- Supporting development of Monitoring Plans and review of Data Management Plans for Investigator Sponsored Studies (ISSs):
- Serving as point of contact for Sponsor, Global Study Management and Therapeutic Area/Medical colleagues to ensure timely and appropriate support deliverables
- Ensuring ISS studies are supported in accordance with global SOPs and other supporting documents
- Assisting GSM in support of Investigator Sponsored Studies activities including process clarification and issue resolution
Reviewing ISS metrics and assists with measurement of compliance to process requirements
Local office based role – office based minimum 2-3 days per week Reports to:
Development Operations Manager Responsibilities:
Project management of UK & Ireland aspect of global and local studies
- Ensuring study meets milestones
- Assessing site quality and performance
As a Senior Associate, Clinical Operations, you will have the following qualifications, skills and experience:
- BA/BS/BSc Degree in life sciences or other relevant field, including a broad experience in life sciences or medically related field.
- Biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or Clinical Research Organisation Company will be considered.
- Good project management experience with ability to lead a small team.
- Experience with clinical systems such as CTMS, EDC, IVRS, Oracle Clinical or other related technology in the pharmaceutical/biotechnology industry.
- Experience working effectively in a team/matrix environment.
- Experience in interactions with outside vendors, e.g., CROs and contract labs.
- Experience covering a variety of therapy areas.
- Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
- Understanding of drug development process.
For more information or to apply for this Senior Associate, Clinical Operations position please contact Russell Oakley on 01246 457733 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL32673 in all correspondence.