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Senior Clinical Study Manager
Location: Cambridge (Flexible/Hybrid)
Department: Clinical Development
Job type: FTC 1 year
Join us and make a difference when it matters most!
At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
Role and Responsibilities
- Undertake the management and conduct of clinical trials, including complex trials to ensure delivery of trials to Good Clinical Practice (GCP), in accordance with project plans and budget to ensure products within the Mundipharma portfolio are compliant with regulatory requirements.
- Undertake study project management according to MRL standard operating procedures (SOP)s and International Conference on Harmonization (ICH) GCP.
- Work across different therapeutic areas and phases of clinical development from Phase I to Post Marketing Surveillance (PMS), including complex studies. Accountable for delivery of assigned clinical trials to time, budget and quality using external service providers (Contract Research Organizations ((CROs)) and internal study team.
- Undertake all steps necessary to ensure Mundipharma complies with the ICH E6 guideline and is inspection ready. Drive the selection process for CRO partners and input into the strategic direction of Clinical Operations activity including approved vendor lists etc.
- Prepare and track trial specific documentation (including protocols, guidelines and plans, updates and reports), with input from other members of the department and internal study team as appropriate.
- Attend investigator site visits with external Clinical Research Associates, as needed, to ensure: understanding of the practical issues of the clinical trial; patient recruitment challenges; investigator relationship building; data quality issues and consistency of protocol adherence across investigational sites
- Support the tracking of clinical study budget including vendor spend and investigator fee management
- Input into clinical development plan discussions for projects including budget and scenario planning; input into process improvement within Clinical Operations. Possibly undertake mentoring and oversight of Associate CPM activities as required.
What you’ll bring
- >4 years previous experience as a Clinical Project Manager; proven track record of delivering international clinical trials to time, budget and quality
- Minimum 4 years of proven experience of delivery of multiple international clinical trials and experience across different phases / therapeutic areas and working with different CROs.
- As per CSM job role plus thorough knowledge of ICH GCP and clinical study processes that supports input into process improvement; clear, repeat evidence of delivery of clinical trials in an international environment; evidence of team
- management in a matrix environment, prioritization ability and attention to detail
What we offer in return
- Flexible benefits package
- Opportunities for learning & development through our varied programme
- Collaborative, inclusive work environment
- We are open to candidates who prefer a four-day working week (0.8 FTE) and welcome discussions around flexible working arrangements.
Diversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.
About Mundipharma
Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.
Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.
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