We are seeking a Clinical Project Manager II to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
In this role, you will be responsible for the execution, oversight and delivery of clinical studies, including study tracking and management of vendor, site, and CRO activities. Candidates should have prior CRO experience and a strong background managing complex oncology and hematology clinical trials. This is a permanent remote opportunity with potential hybrid arrangement depending on location; our office is based in Horsham, Pennsylvania. Only candidates with previous CRO experience will be considered.
Main Job Tasks and Responsibilities:- Organizes and participates in Monitor's and Investigator's Meetings.
- Performs, if necessary, co-monitoring visits for the assigned clinical projects.
- Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
- May act as Feasibility Associate (FEA) after appropriate and documented training.
- Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
- 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 authorizations to finance in a timely manner.
- Regularly track all expenditure and review for consistency with trial budgets.
- Organize quality check of filing of key study documentation.
- Ensure all administrative close-out procedures are completed.
- Follow and comply with the Company's QMS, ISMS and PIMS requirements.
Education, Experience and Skills:- University Degree in scientific, medical or paramedical disciplines.
- Three (3) years (at least) of Project Management experience in the CRO/Pharmaceutical industry or six (6) years (at least) of experience as CM/CRA in a CRO/Pharmaceutical industry.
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
- Experience managing complex clinical studies-oncology and hematology required.
- Excellent English communication skills:written and verbal.
- Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, EDC software, etc.).
- Ability to travel as required.
The Application ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Key words: Project Manager, Clinical Project Manager, Senior Study Manager, Senior Clinical Trial Manager, Study Management, Project Management, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Study Management, Project Leader, Project Lead, complex clinical trials, oncology, hematology, respiratory, CRO, Contract Research Organization, clinical trials, phase I-IV studies
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