Associate Director, Clinical Operations

Help us change lives

At Exact Sciences, we're helpingchange how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

This position is part of the Clinical Affairs Team, which is responsible for planning, executing, managing and closing projects associated with the company clinical study plans, with primary responsibility for management of Clinical Affairs staff. The Associate Director, Clinical Operationsworks as a part of the Clinical Affairs Leadership Team to accomplish department objectives by managing staff, planning, and evaluating department activities. This position provides leadership and support to members of multidisciplinary project teams, internally and externally, and provides professional development and guidance to assigned Clinical Affairs personnel.

This position may be remote.

Essential Duties

Include, but are not limited to, the following:

• Recruit, train, and lead Clinical Affairs staff which may include Clinical Trial Managers, Clinical Research Associates, Clinical Trial Associates, Project Specialists and contractors. Support recruitment efforts for various Clinical Affairs positions.
• Act as a customer advocate throughout the project lifecycle.
• Understand and support project goals including site recruitment, patient recruitment, marketing and PR, as appropriate.
• Ensure Clinical Affairs staff manage resources and timelines relevant to their role including study start-up and implementation activities, including CRO/investigator agreements, central IRBs, contractual agreements, clinical monitoring, clinical study tracking and general study management.
• Participate in clinical vendor/CRO selection.
• Provide management support to Clinical Trial Managers for clinical vendor/CRO oversight.
• Oversee clinical study budget planning, forecasting, and reporting, and partners with designated financial analyst as needed.
• Collaborate with Clinical Affairs leadership on the strategic direction of the Clinical Affairs organization.
• Work with Clinical Affairs leadership on resource planning, FTE and contractor allocation as appropriate.
• Develop and implement clinical study processes to support study operations, staff training, and corporate business processes.
• Accountable for study implementation and execution of clinical study protocols and operational plans, which are consistent with strategic corporate and R&D objectives.
• 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).
• Ensure operational and regulatory integrity of studies and participate in FDA or other regulatory authority inspections.
• Ensure that internal project team members are trained appropriately on proper study conduct and all business processes.
• Manage relationships with consultants to provide adequate support and services for data collection and analysis.
• 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.
• Develop personnel through open communication of job expectations, planning, monitoring, and providing feedback on assigned responsibilities.
• Provide performance feedback and initiate career development discussions and planning for all direct reports.
• Provide coaching, counseling, and disciplining of employees, when required, consistent with the core values of Exact Sciences.
• Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities.
• Consistent demonstration of exceptional leadership qualities, including but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
• 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.
• Demonstrated 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.
• Excellent leadership, planning, and project management ability; exhibiting effective decision making and problem-solving skills.
• 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.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• 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 and means to travel between Exact Sciences locations.
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor's degree in the life sciences or related field.
• 8+ years of experience in clinical research.
• 5+ years of clinical project/study management experience.
• 2+ years of experience managing direct reports or project team members in a clinical research environment.
• Experience with CTMS, EDC, eTMF, and sample management systems.
• Experience in end-to-end trial activities including feasibility, start-up, study conduct, close-out, data management, and report writing of clinical studies, including global studies.
• Experience writing, reviewing, and editing protocols and clinical study reports.
• Knowledge of Good Clinical Practices and all applicable US regulations governing clinical research.
• 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).
• Experience in IVD studies and lab site management.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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