Study Operations Manager (Temporary)
Location: Maidenhead, England
Department: Medical Affairs EU
Headquartered in Emeryville, CA, Zogenix is a biopharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. We are currently looking to hire a Clinical Trial Manager. This is an exciting opportunity to join the Senior Director, Study Operations, Medical Affairs, Europe and support the post-authorisation safety study (PASS). This role is based in our European Office in Maidenhead/office in Emeryville.
The Study Operations Manager (SOM) is responsible for the day-to-day oversight of global clinical and MA trials and will manage the Study Management Team, vendors, trial monitors, and trial sites. The SOM will focus on the management of late phase multinational, multicenter studies, including pediatric clinical trials, with the potential to additionally manage early phase development studies (phase I/II studies). The SOM receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. This position will work closely with a cross-functional team based in the US and EU to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP/GVP and country specific regulatory guidelines, company goals, and budgets. This role works on issues of diverse scope where the analysis of situation or data requires evaluation of variety of factors including an understanding of current business trends. The SOM will be responsible for managing various project goals and delivering a quality study on time and within budget.
Responsibilities and Duties
- Manages the CRO/vendor selection process for the outsourced studies
- Oversees vendor activities to include reviewing monitor visit reports, participating in vendor meetings, supporting development/management of vendor oversight plans/trackers, identifying and mitigating/escalating issues/risks as appropriate.
- Directs the cross functional study team to ensure study start up and execution is according to agreed timelines.
- In collaboration with the Clinical Outsourcing Group, responsible for helping to drive the RFP and RFI process, analyze supplier services, budgets and proposals, conduct bid defense meetings, award vendor, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements, risk based recruitment agreements and imaging agreements).
- Provides oversight and direction to the CRO and vendors providing regional and/or global study services
- Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities
- Participates in the development and review of study documents including but not limited to CRF design, project plans, Vendor Oversight plans, TMF plan Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization
- Identifies potential study issues/risks, escalates as needed and recommends/implements solutions.
- Manages study sites and study related activities including but not limited to site start up, subject recruitment, enrollment, study management, monitoring, site management, clinical trial master files, and data clean up.
- Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization utilizing advanced knowledge to drive the negotiation of the change orders and associated costs to minimize the risk to Zogenix
- May have some responsibility for the oversight and management of the study budget including site and vendor budgets to ensure it remains within agreed variance margins
- Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Senior Management and Study Team.
- Ensures oversight of data and information in study specific systems eg. EDC, CTMS, eTMF is current and accurate.
- May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects, initiatives, and committees including governance vendor meetings to identify and implement process improvements and standards.
- Acts as an advisor and provides guidance to other team members
- May have direct reports and line management responsibilities
- Other duties as assigned
Qualification and Skills
- Bachelor’s degree or equivalent (scientific or healthcare discipline preferred)
- 4+ years study management experience in clinical and drug development
- In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials.
- Experience in managing CROs, specialty labs and outside vendors in global, multinational studies or programs
- Must have negotiation and project management skills with the ability to coordinate across projects/program/timelines.
- Must have high quality written and oral communication skills, with the ability to convey overall engagement objectives and maintain open lines of communication between the internal stakeholders and the service providers.
- Organizationally savvy with the ability to effectively collaborate and influence in a dynamic environment
- Ability to build internal and external relationships
- Able to work under pressure with good problem solving skills to escalate as needed and solve issues efficiently to mitigate risk.
- Line Management experience would be an advantage
- Experience in supporting SOP development and implantation is desired
- Models our core values: Compassion, Courage, Collaboration and Excellence
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
- Fluency in other European languages advantageous but not essential
- Up to 50% travel