Additional Resources Ltd.

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 & 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, imaging vendors, etc.)



* Excellent written and verbal communication and presentation skills



* Excellent organisational and interpersonal skills



* Ability to manage multiple priorities within one or across different projects



* Excellent working knowledge of GCP and current clinical trial legislation



* Thorough knowledge of the clinical development process, ideally from first in human through to regulatory filing for marketing



* Ability to travel in the UK and abroad periodically if needed



* Ability to work in a dynamic small team environment

Desired skills:



* Experience in early phase (I-II) studies



* Experience working with GMO



* CRA/monitoring experience



* Experience of EDC and eTMF; comfortable with electronic systems e.g.

CTMS



* Infectious Diseases and Oncology experience

Important Information: We endeavour to process your personal data in a fair and transparent manner.

In applying for this role, Additional Resources will be acting in your best interest and may contact you in relation to the role, either by email, phone or text message.

For more information see our Privacy Policy on our website.

It is important you are aware of your individual rights and the provisions the company has put in place to protect your data.

If you would like further information on the policy or GDPR please contact us.

Additional Resources are an Employment Business and an Employment Agency as defined within The Conduct of Employment Agencies & Employment Businesses Regulations 2003.














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