Clinical Project Manager/ Senior
Charlene Dutchman at CK Clinical is recruiting for a Clinical Project Manager/ Senior Clinical Project Manager to join a leading Pharmaceutical Biological company, on a full time, permanent basis.
As the Clinical Project Manager, you will plan and manage overall clinical operations for assigned clinical trial(s) including timelines, budgets, resources, vendors and key project deliverables in alignment with Therapeutic Area strategies and goals.
This vacancy is in the Respiratory, Inflammatory and Autoimmunity (RIA) division, although prior therapeutic area experience is not a prerequisite and disease specific training will be provided. The role is focused predominantly on Phase 1 and 2 development programs and is office based at our Cambridge site (a minimum of 3 days/week in the office is required, and this may be more during the first 6 months and based on project requirements).
Key Accountabilities/Responsibilities of a Clinical Project Manager will include:
- Providing matrix management of functional area representatives on cross-functional clinical trial teams, including ensuring proper resourcing for assigned trials, leading clinical trial teams and managing accountabilities for all clinical trial team members.
- Developing operational study level feasibility and recruitment strategies.
- Delivering the approved Study Protocol according to the operational plan.
- Creating study essential documents.
- Developing outsourcing specifications for vendor requests for proposal, leading vendor selection and overseeing vendor management throughout the life of assigned clinical trial(s).
- Ensuring vendors have appropriate plans in place to deliver the relevant aspects of the study.
- Overseeing selection of investigational sites with input from Clinical Development and vendor.
- Overseeing investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with Clinical Research Organisations, study and site personnel.
- Developing and managing study timelines.
- Developing and managing study budget and overseeing site agreement/budget negotiation process.
- Developing and implementing risk management plans with appropriate contingency to assure delivery to quality, budget, and time. Escalating issues to stakeholders as appropriate.
- Reviewing and refining Clinical Operations Plans including vendor oversight and study monitoring.
- Reporting study progress to internal stakeholders.
- Leading ongoing review of data to ensure quality and consistency.
- Planning and conducting investigator meetings and ad boards.
- Submitting trial-related documents to the Trial Master File
- Providing input into non project related activities and development of procedures as requested.
- Participating as appropriate in internal and external audits.
As a Clinical Project Manager, you will have the following qualifications, skills and experience:
- Life sciences degree or nursing equivalent.
- Progressive experience in clinical operations including global project management experience or equivalent or site management and monitoring or equivalent.
- Global experience of drug development, ideally obtained in a biotech/pharma/CRO setting.
- Experience of vendor selection and oversight.
- Thorough understanding of country level regulations, ICH and GCP guidelines.
- Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety and regulatory affairs.
- Demonstrated ability to lead a cross-functional team in a matrix environment.
- Strong focus on delivery of multiple tasks to time and quality. Willingness and ability to take accountability for the delivery of tasks assigned to self and cross-functional trial team.
- Strong verbal and written communications and presentation skills.
- Proven ability to collaborate with internal and external stakeholders.
- Strong leadership, management and organizational skills, conflict resolution, and team building skills.
- Ability and willingness to travel (international and domestic, approximately 5-10 trips/year).
For more information or to apply for this Clinical Project Manager position please contact Charlene Dutchman on 01246 57 77 33 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer and 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 CL33689 in all correspondence.