Contract Clinical Study Manager

Proclinical is recruiting for a Clinical Study Manager position for a global pharmaceutical company focused on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

The Clinical Study Manager incumbent will join a dedicated team of professionals and become an important part of the Clinical Study team in a progressive and innovative company. This is a contracted role with the company's London-based team.

Job Responsibilities:

• Initiating Change Order (CO) and Change Negotiation Form (CNF) for vendors in collaboration with Business Operations.
• Ensuring invoice review of vendors, track vendor spend against plan, and providing vendor budget updates to SETL.
• Providing monthly accrual for vendors to SETL.
• Ensuring investigatory payments: site setups, pass-through processing, visiting payment processing and funding processing.
• Ensuring vendor oversight plans are created and maintained.
• Contributing to the selection of CRO and vendors.
• Contributing the development of standard metrics used to routinely monitor study activities.
• Performing day-to-day management of the CRO and other vendors as needed.
• Monitoring all vendors/CRO performances, communication vendor expectations, and tracking vendor performance metrics at a study level.
• Ensuring that vendors/CRO are adequately trained to perform their functions.
• Escalating vendor/CROP issues to SETL when appropriate.
• Establishing/creating the study-specific oversight plains in collaboration with Business Operations.
• Driving the development and adherence to Clinical Operations owned study specific plans.
• Ensuring protocol deviation meetings are conducted per plan.
• Facilitating internal audit/corrective and preventive action (CAPA) management; contribute to the resolution of CAPA/Quality Event (QE) input in Trackwise.
• Managing TMF filing of Clinical Operations study documentation.
• Conducting or participate in inspections readiness activities in collaboration with DSQ.

Skills and Requirements:

• A bachelor's degree, or equivalent experience in a Life Science, Physical Science, Biological Science or Nursing degree.
• Comprehensive experience in CRA, or as a Clinical Project Manager.
• Demonstrable personnel management experience.
• Demonstrable medical device experience.
• Knowledge of Good Clinical Practices is essential.
• Demonstrable understanding and application of regulations and standards applied in clinical areas is required.
• Advanced project management skills with the ability to handle multiple projects required.
• Relevant industry certifications preferred.
• Strong written and oral communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 440 0639 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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