Clinical Study Planning Manager
Lucy Stendall at CK Clinical is recruiting for a Clinical Study Planning Manager to join a biopharmaceutical company who operate on a global level, at their site based in either Cambridgeshire or Uxbridge on a contract basis for a 12 month period initially.
This role sits within the development operations organization, and assists the Clinical Research Manager (CRM) and development functions in tracking, documenting, and ensuring quality and timely delivery of all clinical trial deliverables.
The main purpose of the role will be to:
- Be accountable for co-developing and monitoring the implementation of high-quality, realistic, cross-functional, clinical trial timelines for the companies drug development programs from study concept through completed clinical study report.
- Assist study teams in developing contingency and/or risk mitigation plans to ensure timely delivery on clinical milestones.
- This role ensures effective collaboration with other functional planning groups, alignment with the Integrated Project Plan timelines managed by R&D Project Management, and works with the CRM and Clinical Study Team (CST) to monitor progress against the plan and against established process metrics.
- The role is within the development operations organization, and assists the Clinical Research Manager (CRM) and development functions in tracking, documenting, and ensuring quality and timely delivery of all clinical trial deliverables.
- Be accountable for co-developing and monitoring the implementation of high-quality, realistic, cross-functional, clinical trial timelines for drug development programs from study concept through completed clinical study report.
- Co-develop and validate study-specific timelines- Accurately maintain clinical study timeline information in the companies data control systems (e.g., APECS)
- Assist in all aspects of initiating, planning, executing, controlling, and risk management of all clinical trial activities
- Facilitating communication of information on clinical trial status, changes, and issues to team members and stakeholders (e.g., dept. heads)
- Contributing to the development of high performing CSTs and functional teams
- Leading special projects as assigned
- Rapidly identifying variances within clinical study timelines that require corrective action
- Adhering to all the companies policies, clinical development processes, SOPs, and clinical project management processes
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Previous experience supporting clinical trial management and/or oversight
- Provided project management for projects /initiatives/teams;with experience communicating project status, changes, and/or issue (includes knowledge of project management tools and processes (e.g. MS Project), also computer literacy, including word processing, presentation, and spreadsheet applications
- Experience of global working and stakeholder management
- BA/BS/RN degree
- Experience in life sciences, including relevant experience in biopharma clinical product development and clinical research or clinical operations experience
- Experience with project management tools (MS Project, PowerPoint) processes and methods
- Excellent knowledge of Clinical Development and Project Cycle Excellent organisational and time management skills Excellent communication skills
For more information or to apply for this position, please contact Lucy Stendall on 012464577 or by email on email@example.com Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL35080 in all correspondence.