Senior Clinical Study Manager
This is a fantastic job opportunity for a Senior Clinical Study Manager to be based in London. This is an international organisation with over 1300 employees, they specialise in the development and commercialisation of innovative biopharmaceuticals. The Manager is an essential position within Global Medical Affairs Study Management & Data Analytics focusing on leading day-to-day management activities across assigned trial(s) to ensure high quality deliverables. The Manager is responsible for the implementation of study(ies) across the study lifecycle, including but not limited to protocol development, study oversight (timelines, planning, and budgets), quality, compliance, meeting facilitation, and vendor management.
The individual in this position exhibits advanced level skills related to communication, compliance, clinical trial, and project management. S/he has advanced technical skills related to compliance. S/he has foundational problem solving and strategic planning skills and is developing people management capabilities.
- Responsible for vendor selection, management and definition of performance metrics in collaboration with cross-functional business partners
- Accountable for vendor performance and communication of expectations at the trial(s) level
- Accountable for the final review of the site-level documentation and approval for initiation
- Define the country and site selection strategy and country-level feasibility assessment
- Accountable for the development and management of detailed timelines for assigned trials(s)
- Facilitate short- and long-term planning for assigned trial(s)
- Approve the study-level plans, including the monitoring plan
- Participate in the writing of study documents, including but not limited to protocols, informed consent document templates, regulatory reports, statistical analysis plans and study reports
- Accountable for product forecasting across all supply chain activities, including shipment and reconciliation
- Develop and manage the budget for assigned trial(s), including tracking monthly spend against planned, and provide GMAF SMDA leadership with updates
- Facilitate and manage monthly study team meetings, including review and approval of agendas and minutes and distribution of study updates within team
- Collaborate with the Medical Directors and/or Medical Science Liaisons to support site and/or Ethics Committee questions about assigned trials(s)
- Responsible for trial master file (TMF) activities including establishing the TMF plan, managing the reconciliation process, and providing study-level content for filing into the TMF
- Accountable for the development and utilization of metrics and management reporting tools for efficient trial execution
- Responsible for participating in the design and utilization of data review tools and data collection initiatives by assigned Study Team members, and resolution of identified issues
- Collaborate with pharmacovigilance on the reconciliation of events in the clinical and safety databases
- Lead or participate in the development and implementation of study-level corrective action plans
- Accountable for corrective and preventative actions resulting from site audits
- Anticipate, identify, and collaboratively address issues that may arise at a study level
- Oversee and provide guidance to Trial Specialists throughout the trial conduct
- Manage performance of direct reports, including facilitating training and development
Skills and Requirements:
- A Manager demonstrates advanced competence in communication, along with foundational skill in leadership, strategic thinking, planning, problem solving and decision making. This includes (but is not limited to):
- Distilling complex issues to simple terms, while driving information dissemination up and down the organization to influence appropriate outcomes
- Ensuring that team roles and responsibilities are clearly defined, understood, and fulfilled
- Contributing to the development of a motivating team/work environment by upholding positive morale and encouraging high performance
- Demonstrating an ability to recognize, understand, articulate and respond promptly to issues that arise, escalating as appropriate
- Demonstrating robust knowledge of GCP and GVP guidelines and their impact on each stage of the trial (start-up through close-out)
- Ability to identify and mitigate compliance risks across a clinical trial
- Demonstrating command of site management and trial oversight
- Demonstrating an ability to lead efforts in identifying and selecting vendors for assigned clinical trials
- BA/BS or higher in life or health sciences preferred. Industry or relevant experience in lieu of education accepted
- 5 years of relevant experience in clinical science, clinical trial or site management, medical affairs, and/or drug development
- Some line management experience (0-1 years) preferred
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 4400 639 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.