Clinical Project Manager II

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Job description

*Clinical Project Manager *will ensure studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory guidelines.
* Key Responsibilities: *

* To lead local/ regional study management teams in implementation of clinical trials ensuring the studies are performed and conducted in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory requirements for the allocated study
* Define and monitor project scope, timelines and deliverables from project initiation to close out. Ensure project plan aligns with contract requirements, and address any reconciliation required
* Study oversight and status reporting study targets discussed and agreed, includes the development of study timelines, communication, risk and quality plans, team training and oversight
* Schedule, plan for, and document regularly scheduled project team meetings. Assess project issues, propose resolutions to the project team, management and Steering Committee as necessary, and then track implementation of resolution through to completion.
* Ensure the overall quality of project services and deliverables by documenting project/clinical trial progress to ensure completeness of documentation and data collection, management of supplies and resources in adherence with the project timelines, budgets and quality standards including central laboratory (if applicable) and contract/academic research organisations.
* Accountable for status of studyies communicated regularly with study team and management and that unresolved issues are escalated appropriately
* Responsible for maintenance of TMF
* Preparation of site agreements, contracts, and financial/site payment tracking during study conduct.
* Protocols developed in conjunction with Chief Operating Officer and Investigators
* Attendance of and contribution to Investigator meetings
* Ensure site and outsourced CRO staff trained in protocol specific procedures
* Management of ethics, regulatory requirements and local applications
* Liaison with external customers e.g. Steering Committees, Investigators, Study Nurses and Clinical Trial Pharmacists etc.
* To provide the day-to-day operational management of CROs and vendors ensuring delivery against contracted scope of work for the allocated region
* Plan and manage study budget
* Contribute to process improvement
* Assist with training and with preparation of training material for Study support roles

* Desired Skills and Experience: *

* Proven clinical trials project management and leadership experience
* Life science or other relevant degree
* Excellent Project Management skills
* Excellent presentation, communication and organizational skills
* Good attention to details
* Excellent interpersonal skills and a good team player
* Cost and Financial oversight
* Proven ability to develop and update working practices
* Flexible and effective project management, communication and negotiation skills
* Ideally experience overseeing outsourced CRO work
* Ideally a strong understanding of cardio vascular disease and treatment

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