Director Clinical Program Management
A leading Pharmaceutical company, delivering life-transforming medicines for serious diseases, is currently recruiting a Director of Clinical Program Management at their office in London. This is an excellent opportunity to work in a flexible environment in a science and technology company.
- Responsible for the overall success of the clinical study team(s) within a program(s).
- Maintaining an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested.
- Providing operational insight into feasibility, timeline and cost estimates during clinical program/study development
- Overseeing clinical study timelines within a clinical program(s).
- Providing input and operational insight into Clinical Study Concepts (CSC).
- Reviewing plans and provision of clinical operations expertise during protocol design, feasibility, study start-up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM
- Overseeing clinical study budgets within a program, ensuring review, presentation and approval of the initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
- Ensuring timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
- Driving decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation.
- Acting as point of contact for clinical program and study level escalation.
- Reviewing key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress.
- Providing proactive creation and implementation of risk mitigation strategies.
- Providing innovative and flexible operational solutions and options to the cross-functional and development teams; assists in preparing scenarios for creative solutions to operational challenges.
- Driving the strategy and oversight for vendor selection and management within a clinical program(s).
- Managing the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts.
- Identifying and recommending changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development.
- Attending and representing CTM for a program(s) at review committee meetings as appropriate.
- Participating in CRO governance meetings as needed for clinical program(s).
- Participating in Joint Meetings with Collaborative Partners at the study level and program level.
- Ensuring inspection readiness throughout the clinical program lifecycle and is the cross-functional leader for Regulatory Authority Inspections.
- Responsible for CTM resource forecasting and resource allocation for clinical studies across one or more clinical programs.
- Responsible for direct supervision of CTM staff and line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
Skills and Requirements:
- 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.
- May require up to 25% travel
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 Matthew Pike at 0207 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.