Description
Purpose: The Clinical Project Manager (CPM) will support the product development and overall clinical- regulatory strategy. The CPM will oversee initiation, progress and conduct of US and OUS clinical studies and publication studies to ensure compliance with Good Clinical Practices (GCP), SOPs, other applicable regulations. They are also responsible for developing Clinical Evaluation Reports to meet European regulatory requirements.Roles and Responsibilities:
- Manage and execute clinical research activities essential to the successful management of pre and post -market clinical studies under direction from Clinical affairs manager/director.
- Works closely with core team member to facilitate program/project strategies.
- Responsible for the management of the clinical studies including investigator selection, analysis of potential patient recruitment, preparation of study related documents, organizing IRB/EC submissions with follow thorough to ensure successful outcome
- Monitor clinical study data at sites to ensure regulatory and protocol compliance.
- Manage the Contract Research Organization (CRO)- initial identification of suitable partner, development of CRO work charter and interactive management of CRO to ensure project success
- Conduct other site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim site visits, and study close-out visits), as required.
- Generate clear and concise trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc) and, as required, clinical summaries.
- Manage investigational device accountability, CRF retrieval and query distribution to sites
- Ensure clinical studies are conducted in a timely manner and within site budgets.
- Escalate issues to senior staff on a timely manner
- Prepare reports in support of external physician advisory committees.
- Develop reports for submission to regulatory agencies.
- Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines)
- Develop Clinical Evaluation reports to support technical files
- Conduct literature searches and obtain electronic versions of articles in support of ongoing bibliography and meta-analyses / add meta-data to articles in library in order to track types of publications and extract metrics
- Develop clinical evaluation reports to support technical files.
Qualifications:
- At least 2-5 years of experience in clinical study planning, execution from protocol development, site execution, monitoring and writing final study reports.
- At least 2-3 years of medical writing experience.
- Preferred 1-2 years of experience in conducting clinical literature searches, reviewing literature and writing summaries
- Preferred 1-2 years of experience in writing Clinical Evaluation Reports to meet MDD (CE) requirements
- Comfortable in a hospital environment, with experience working with nurses and surgeons (3-5 years)
- Bachelor's degree in scientific field, Master's degree in scientific fields or MD preferred
- Must be able to travel up to 20-30%
- Must be able to manage multiple projects across numerous surgical disciplines
- Good communication and interpersonal skills with high attention to detail and organization
To find out more about Real please visit www.realstaffing.com