Senior Project Manager
An international contract research organization is seeking to recruit a Senior Project Manager to join their company in a home-based capacity. The CRO offers a wide range of comprehensive, clinical research services to the pharmaceutical, biotechnology, and medical device industries. This is an exciting opportunity to work with a company that focuses on delivery high quality data and achieving targeted enrolment.
- Work independently with periodic direction and review from PM Management.
- Actively participate in proposal development teams and participate in bid defences for assigned RFPs.
- Serve as the primary sponsor contact at the project operational level. Establish effective relationship with the Sponsor team to ensure that Sponsor needs, and expectations are identified.
- Establish regular communication with the Sponsor. Escalate/communicate issues and propose solutions to problems.
- Ensure effective communication channels includes all relevant team members (internal team, Sponsor and third-party vendors) and comprises all project specific topics such as scope of work, timelines, project goals, technical information and Sponsor input.
- Report to appropriate line managers any anticipated resource or training needs or performance issues.
- Update the Project Review Form and financial Progression Chart and discuss these forms at the monthly Project Review Meeting.
- Participate in the Business Development handover meeting to understand the history of the project, the scope of the contract and any Master Services agreement in place for the Sponsor.
- Review the project contract and associated budget to have good understanding of the contract scope of work, budget, project timeline and payment schedule.
- Identify resources needed and request resources from appropriate functional heads. Assign individual project responsibilities. Monitor ongoing resource needs for assigned project.
- Initiate and manage kick-off meeting with internal team, third party vendors and Sponsor to facilitate the understanding of the scope of work.
- If appropriate, negotiate scope of work and manage third party vendors including but not limited to: central laboratories, storage units, couriers, meeting planners, sub-contractors for printing, monitoring, data processing, etc. Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
- Establish regular communication within the project team and co-ordinate study specific training for the project team.
- Set-up, maintain and develop project tracking to review study progress. Ensure up-to-date tracking.
- If appropriate, ensure the development of Project Specific Operating Procedures by functional area.
- Ensure the creation, execution and revision, as appropriate, of the project plan and filing plan.
- Hold team meetings on a regular basis to assess the overall status of the project and to ensure pro-active project management.
- Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc. Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
- Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
- Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
- Submit invoice requests, trial related invoices and payment authorisations to finance in a timely manner. Regularly track all expenditure and review for consistency with trial budgets.
- Ensure project is archived and all documentation is returned to Sponsor as specified contractually.
Skills and Requirements:
- Degree in Life Science, nursing background and/ or combination of education/experience.
- Minimum 5+ years' experience of project management for clinical trials, including experience with oncology, asthma, etc.
- Successfully managed a large size trial from set-up, until the end and final deliverables.
- Clinical trial phases I-IV, preferably emphasis with phases II-III.
- Multiple therapeutic area experience, such as, oncology, infectious disease, respiratory, GI, etc.
- Maintain up-to-date knowledge of ICH-GCP, EU CT Directive and FDA regulations.
- Proficient in the use of computer software systems (Word, Excel, PowerPoint, Share Point, CTMS, timesheet software, EDC software, etc.)
- Prior experience attending bid defences and kick-off meetings.
- 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 Theodora Savlovschi-Wicks at +44 203 752 0314 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.
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