Director, Clinical Study Management

ProClinical has a fantastic job opportunity for a Director, Clinical Study Management to be based in London on a permanent basis. This is an international organisation with over 1300 employees, they specialise in the development and commercialisation of innovative biopharmaceuticals.

Job Responsibilties:

• Accountable for study level governance across assigned products
• Accountable for annual budget development process, managing spend, long range planning, and providing SM leadership with budget updates
• Accountable for vendor selection, vendor relationship management, and review and approval of vendor contracts and budget
• Provide leadership and guidance on SM trial start-up, management, and oversight
• Accountable for quality, timeliness, and compliance of implementation of global programs across assigned products
• Accountable for product forecasting across all supply chain activities
• Accountable for periodic regulatory reports
• Provide key trial and product updates to all levels (e.g. matrix team meeting)
• Facilitate and manage quarterly cross-functional product team meetings
• Collaborate cross-functionally in the development and/or implementation of controlled documents
• Responsible for identification, resolution, and escalation of risks, issues, and trends across assigned products
• Accountable for quality and compliance, including responses to internal/external audits and corrective and preventative action plan
• Mentor and manage performance of direct reports, including facilitating training and professional development
• Accountable for resourcing plans and recruitment of SMDA staff
• Lead the cross-functional Program Team, including facilitating development of an integrated data evidence plan to support the post-marketing lifecycle management of approved products
• Develop and maintain strategic business relationships internally and externally for the post-marketing lifecycle management of approved products
• Provide input or lead departmental process improvement and company initiatives
• Work with Head of SM to develop plans for organizational changes

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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