Contract Late Phase Clinical Study Manager
A global biopharmaceutical company is advertising a vacancy for a Late Phase Clinical Study Manager. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD), and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide. This will be a contract role.
- Supporting/coordinating protocol development and finalisation.
- Managing Study Governance (post SDC).
- Supporting/coordinating all internal study governance processes (e.g. MEORT, MARC, LSPC, Clinical Challenge).
- Providing input into the selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs).
- Supporting strategic handover meetings and kick off meetings.
- Performing CRO oversight to help ensure project delivery within time, cost, and quality.
- Collaborating with CRO/ESP to ensure that study operational aspects are effectively undertaken and that they have clear remits for delivery.
- Managing study specific issues and escalations with ESPs/CROs.
- Supporting Project team set-up and study sourcing activities.
- Supporting effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other internal cross functional global roles.
- Reporting study updates for areas of responsibility from a time, cost, and quality perspective to internal stakeholders (e.g. Evidence Delivery Associate Director(EDAD)).
- Supporting the implementation and upkeep of an effective communication approach, as well as roles and responsibilities between the BPM Evidence stakeholders, company, and External Service Providers.
- Coordinating the efforts/input of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during project design and delivery.
- If leading a study, developing, and maintaining the overall study budget (internal and external study costs).
- Ensuring transparency over areas of budget responsibility by updating through relevant systems (s.a. ACCORD) and platforms (PPC meetings) and obtaining approval for budget changes.
- Working with procurement on project agreement and manage subsequent out of scope changes for ESP/CRO.
- Managing and reconciling Contracts, POs, and invoices.
- Supporting financial audit readiness and Sox attestation as needed.
- Supporting the delivery of projects to agreed timelines (scorecard), within the approved budget and according to quality standards.
- Supporting global oversight over the operational study start up, implementation, and closure and ensuring inspection-readiness.
- Supporting the implementation of study-related change management within business strategy; assessing scope changes.
- Ensuring Compliance with company Procedural Documents, Standards, and Policies, local regulations, and international guidelines at any time; and reporting compliance breaches.
- Undertaking feasibility assessments with internal and external stakeholders.
- Managing study systems reporting.
- Managing study Governance processes.
- Managing internal and external stakeholders.
- Providing finance Management support.
Project Managing owned study areas to deliver according to cost, time, and quality.
- Supporting study Risk Management and Quality Management activities.
Skills and Requirements:
- Demonstrable experience and education in a relevant or similar field.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Matt Pike at +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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