ProClinical is currently advertising a vacancy for a Contract Lead Clinical Study Manager position with an international biotechnology company. This company, which prides itself on its leading work in the fields of neurodegenerative diseases, haemophilia, and autoimmune disorders, is recruiting the Study Manager to join their UK-based team on a 12-month contract basis.
The Contract Lead Clinical Study Manager will partner with the Medical Research team, and other functions, to develop operationally feasible and clear protocol concepts and final protocols. They will leverage Phase and operational expertise to establish study level operational strategies in alignment with the Clinical Development Plan (CDP) and program level strategy, and independently oversee one or more trials by establishing the operational strategy and securing excellence in execution through the CRO partners.
Job Responsibilities:
- Developing scientifically robust, operationally feasible and clear protocol concept and protocols, along with feasible protocols and robust data monitoring plans.
- Leveraging appropriate on-going data reviews to identify and mitigate patient, study design, data, or study conduct issues.
- Ensuring all operational aspects support end point integrity and data validity.
- Developing and leveraging Phase expertise, therapeutic knowledge, and internal and external data to develop protocols and expert operational strategies for one or more clinical studies.
- Developing operation strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead.
- Overseeing the tactical execution of the operational strategy by the partner CFO; effectively leading the study through oversight of the CRO.
- Driving performance, quality, timelines, and relationships through the CRO partnership model.
- Charing the Study Management Team in partnership with the CRO study Lead of the Study Management Team; ensuring the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.
- Partnering with GCO Vendor Management to escalate issues, sharing best practices, and leveraging the Vendor Operations Relationship Manager for issue resolution.
- Championing best practice development in Phase planning and seeking opportunities for innovation and efficiency with the Clinical Operation Management group.
- Seeking interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phase.
- Following established procedures and SOPs; seeking ways to improve and streamline processes to support the GCO CRO outsourcing model.
- Embodying a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model.
Skills and Requirements:
- At least B.A. or BS. In a scientific discipline, though an advanced degree is preferred.
- At least 10 years of clinical research study management experience; at least 4 of these years must have been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations.
- Prior CRO or investigator site and/or monitoring experienced a preferred bonus.
- A deep understanding of clinical development within one or more Clinical Trial Phases (Phase I-IV), and a working understanding of cross functional drug development.
- A scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas.
- An ability to establish operational plans and supporting the CRO in the execution of the plans.
- Requiring a balance of scientific and operational/project management and team leadership expertise.
- Able to build effective relationships across the organisation.
- Excellent project management skills, including risk assessment and contingency planning.
- Demonstrably effective CRO management skills, and the capability of adapting to the GCO outsourcing model.
- Excellent interpersonal skills, including leadership, communication, management, organisational, persuasion, problem solving, conflict resolution, negotiation, and team building abilities.
- A thorough knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development.
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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