Summary of Major Responsibilities
This position will be part of the Clinical Operations Team, which is responsible for executing, managing and conducting projects associated with the company clinical study plans. The project manager manages, executes and reports on clinical study operations; and provides support to members of the multidisciplinary project team, internally and externally. This position functions under the guidance of the Sr. Director of Clinical Affairs.
Essential Duties and Responsibilities include but are not limited to the following:
- Act as a customer advocate throughout the project lifecycle.
- Understand and support global project goals including site recruitment, patient recruitment, marketing and PR, as appropriate.
Necessary Education and Experience
- Implement approved clinical study protocols and operational plans, which are consistent with strategic corporate and R&D objectives and assumes primary accountability for the ongoing progress of those plans on assigned studies.
- Coordinate with Clinical, Marketing, and Operations management to identify goals and scope of clinical study projects. Manage and execute the overall project scope and timelines.
- Initiate and train sites to the study protocol. Ensure proper site adherence to clinical research regulations.
- Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, central IRBs, and contractual agreements.
- Support the management and oversight of CROs and other clinical study related vendors.
- Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device.
- Ensure maintenance of document standardization through the use of model documents, templates and appropriate peer review.
- Ensure the appropriate development of all documents by CROs including but not limited to: study documents, including informed consent forms, case report forms and instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
- Ensure maintenance of project files according to applicable regulations, guidelines, and corporate policy (e.g. GCPs and company SOPs).
- Assume primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
- Ensure the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities, as required.
- Ensure operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
- Develop and maintain detailed timelines and resource projections for all programs.
- Provide routine status reports and updates regarding the progress of programs.
- Work with Sr. Director of Clinical Affairs to help ensure that internal project team members are trained appropriately to ensure proper study conduct.
- Prepare internal and external memos, reports, documents, and correspondence required to properly manage and document activities on the studies.
- Manage the tasks that are not associated with in-life component of studies including, but not limited to: development of database, statistical analysis and report writing.
- Prepare and review clinical data for analysis. Manage relationships with consultants to provide adequate support and services for data collection and analysis.
- Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
- Attend off site-meeting and conferences, as needed.
M andatory Skills and Qualifications
- Bachelor’s degree
- Minimum 7 years’ experience in clinical research with at least 3 years clinical project management.
- Experience qualifying & managing external vendors (e.g. CRO, Call Center, Central labs, etc.)
- Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies.
- Experience writing, reviewing and editing protocols and clinical study reports.
- Demonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research, as well as working knowledge of the FDA submission process including IDE, PMA, and 510(k).
- Global study management and/or medical device study experience preferred
- Demonstrates problem-solving and interpersonal skills. Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
- Excellent organization and communication skills, including experience dealing with decision makers, such as physicians, IRB members, and FDA staff.
- Strong desire to join a small company and work in a fast paced environment.
- Ability to work independently and manage multiple timelines, while maintaining the team focus.
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
- Ability to sit and/or stand for an extended period of time.
- Ability and willingness to travel (by land and air), both domestically and internationally, on occasion.
- Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
- Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
- Ability to manage multiple deadlines.
- Ability to lift and move up to 40 pounds on an occasional basis.
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