INSERT INTO tblcactusclickthroughs (CTR_AgencyID, CTR_ConsultantID, CTR_VacancyID, CTR_AgentsRef, CTR_JobTitle, CTR_LanguageID, CTR_Date) VALUES ('2452', '2638', '58467', '23185605', 'Clinical Study Manager', '1', NOW())

Clinical Study Manager

Clinical Study Manager - Oxford

Salary: Very Competitive

2 Posts to fill

The Company:

Our highly reputed client is looking for a Clinical study manager to join their team in their Oxford office. The company specialises in developing vaccine products to treat and prevent infectious disease and cancer. The firm offers generous benefits, including a competitive salary, professional development and other incentives.

Main purpose of job:

To assist with the clinical activities to support the company in research and development projects. All activities carried out with regard to time, cost and quality and in accordance with SOPs, ICH/ GCP guidelines and local regulations.

Key responsibilities include:

* Study team coordination and leadership.

* Oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality.

* Responsibility for preparation of study documentation and coordination of document review, e.g. protocols, IBs, DSURs, ICFs, CSRs.

* Selection and oversight of assigned CROs, vendors or contract monitors (CRAs), as appropriate.

* Selection of suitable clinical sites in collaboration with other members of the study team or CROs, as appropriate.

* Periodic co-monitoring with contract CRAs or CROs as necessary for each study, to ensure high quality monitoring and site management.

* Set up and management of clinical contracts (including Clinical Site Agreements).

* Coordination of IRB/IEC and other required study submissions, and provision of essential documents to the Regulatory Head (or CRO if delegated) for regulatory submissions.

* Preparation of study budgets, forecasting and accruals.

* Thorough documentation of study team activities, decisions, actions and risk assessments.

* Active management of clinical trials supply requirements in collaboration with 3rd party storage and distribution specialist

* Oversight of Sponsor Oversight File and/or TMF creation and maintenance by Clinical Trial Administrator, to ensure `inspection- readiness` of documentation at all times.

* Active acquisition and furthering of therapeutic area knowledge appropriate to assigned studies.

* Assist with departmental development work e.g. SOP review/writing and process improvements initiatives.

* Develop and maintain relations with sites and KOLs.

Personal Abilities and Traits:

* Demonstrates personal drive and goal orientation.

* Self-motivated taking personal pride in delivering on personal and corporate objectives.

* Enthusiastic and flexible to change.

* Demonstrates strong organisational and prioritisation skills to manage a diverse workload.

* Able to interact with individuals at all levels of the organisation.

Essential Knowledge, experience and skills:

* BSc or equivalent

* Clinical study management experience within a pharmaceutical, biotech or CRO company

* Experience in oversight of external vendors (CROs, central labs,

This job vacancy is no longer active.

Please feel free to look at similar jobs below or use our executive job search facility to find the right job for you.

• Senior Project Manager
  Senior Project Manager (Plumbing) £55,000 - £70,000 (depending on experience) Monday to Friday 7.30am - 4.30pm Holiday, Pension, Car Allowance, Hy...
• Senior Project Manager
  Senior Project Manager (Plumbing) £55,000 - £70,000 (depending on experience) Monday to Friday 7.30am - 4.30pm Holiday, Pension, Car Allowance, Hy...