Principal Clinical Study Manager
Summary of Major Responsibilities
This position will be part of the Clinical Affairs Team, which is responsible for planning, executing, managing and closing projects associated with the company clinical study plans. The Principal Clinical Study Manager (Principal CSM) is a proven leader in clinical program management in the device industry, and manages, executes and reports on clinical study operations. The Principal CSM provides leadership and support to members of the multidisciplinary project team, internally and externally and serves as a mentor to other Clinical Study Managers within the Clinical Affairs team.
Essential Duties and Responsibilities
- Partner with the Clinical Affairs Management team to improve clinical study processes, procedures and to foster Clinical Affairs employee development.
- Provides guidance and best practices to Clinical Affairs team and acts as a mentor to Clinical Study Managers.
- Act as a customer advocate throughout the project lifecycle.
- Foster Key Opinion Leader (KOL) relationships with cross-functional stakeholders.
- Understand and support strategic global project goals and translate strategy to study planning and execution.
- Leads the development of trial related documents (e.g., Informed Consent Form, Study Monitoring Plan, Patient Guide, Project Plan, etc.) as required
- 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.
- Develop, manage, and track clinical trial budgets to include review and approval of all vendor and site payments. The Principal CSM is also responsible for notifying management of anticipated change orders and/or budget adjustments.
- Coordinate with applicable cross-functional teams (e.g., R & D, Operations, Exact Sciences Laboratories) to identify goals and scope of clinical study projects. Manage and execute the overall project scope, budget, 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.
- Oversight of CROs and other clinical study related vendors as applicable.
- Plan for and manage 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 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.
- Develop and maintain 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.
- Work with Clinical Affairs Management Team to ensure that internal project team members are trained appropriately to ensure proper study conduct.
- Prepare and distribute appropriate communications required to properly manage and document activities on the studies.
- Facilitate the completion of database development, statistical analysis and clinical study report writing.
- 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-meetings and conferences, as needed.
- Experience qualifying & managing external vendors (e.g. CRO, Call Center, Central labs, etc.).
- Global clinical study management.
- Experience leading project 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.
- Experience in collaborating with biostatistics. Review of tables, listings, figures for clinical study reports, interim and final study analyses.
- 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).
- 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 work in a fast-paced environment.
- Ability to work independently and manage multiple timelines, while maintaining the team focus.
Education and Experience
- Bachelor’s degree in the health or life sciences, or a related field. Master's degree desirable.
- 15+ years of clinical research experience.
- 10+ years clinical study management experience.
- 7+ years managing project team members in a clinical research environment.
- 2+ years of device/IVD experience preferred.
- 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 for a wide range of issues of varying complexity.
- Ability to manage multiple deadlines.
- Ability to lift and move up to 40 pounds on an occasional basis.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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