Exact Sciences Corporation

Senior Clinical Study Manager

Job Locations US-Remote
Req No.
2021-8948
Category
Clinical Operations
Type
Regular Full-Time

Summary of Major Responsibilities

This position will be part of the Clinical Operations Team, which is responsible for planning, executing, managing, and closing projects associated with the company clinical study plans.  The Senior Clinical Study Manager (Sr. CSM) is a proven leader in clinical program management in the device industry, and manages, executes, and reports on clinical study operations. The Sr. CSM provides leadership and support to members of the multidisciplinary project team, both internally and externally.  

Essential Duties and Responsibilities

  • Act as a customer advocate throughout the project lifecycle.
  • Ability to support global projects with an understanding of site recruitment, patient recruitment, marketing, and PR, as appropriate.
  • Lead the development of study specific protocols, consent forms, and other trial related materials (e.g., Study Monitoring Plan, Patient Guide, Project Plan, etc.), as required.
  • Ensure the appropriate development of all documents by Contract Research Organization (CROs); including, but not limited to, study documents, such as 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; notify management of anticipated change orders and/or budget adjustments.
  • Implement approved clinical study protocols and operational plans, which are consistent with strategic corporate and R&D objectives, and assume primary accountability for the ongoing progress of those plans on assigned studies.
  • 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.
  • Support the management and 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 devices.
  • 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 ensure 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 participate in FDA or other regulatory authority inspections, as needed.
  • Develop and maintain detailed timelines and resource projections for all programs.
  • 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 resource and mentor for other Clinical Affairs personnel.
  • 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.
  • Ability to frequently and accurately communicate with employees, customers, and vendors in person, via 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.
  • Strong 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 ability to deal 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.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Regular and reliable attendance.
  • Ability to work designated schedule.
  • Ability to lift up to 10 pounds for approximately 5% of a typical working day.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
  • Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
  • Ability to comply with any applicable personal protective equipment requirements.
  • Ability and means to travel between Madison locations.
  • Ability to travel 20% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications:

  • Bachelor’s degree in the life sciences or related field.
  • 7+ years of experience in clinical research.
  • 7+ years of experience leading project operational teams through the start-up, study conduct, data management, and report writing/review of clinical studies.
  • 5+ years of experience qualifying and managing external vendors (e.g., CRO, Call Center, Central labs, etc.).
  • 3+ years of clinical project/study management.
  • 3+ years of experience writing, reviewing, and editing protocols and clinical study reports.
  • 2+ years of device experience.
  • Strong knowledge of Good Clinical Practices and all applicable U.S. regulations governing clinical research; preferred with documentation of GCP training.
  • Authorization to work in the United States without sponsorship.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications:

  • Working knowledge of the FDA submission process; including IDE, PMA, and 510(k). 
  • International Study experience and GDPR implementation.
  • Sample management system set-up experience.
  • Experience managing clinical project team personnel.

We are 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 are available to any applicant or employee for inspection upon request.

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