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 Manager, Clinical Affairs works 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, both internally and externally, and provides professional development and guidance to assigned Clinical Affairs personnel.
This role will be responsible for managing a portfolio of urology post-marketing investigator-initiated studies (IIS) and collaborative studies.
Essential Duties and Responsibilities
Strategic operational Management of Urology post-marketing portfolio of IIS and collaborative studies with attention to improving efficient execution of review and approval processes, contracting, correspondence with study sites, developing supporting clinical documents (e.g., IRB / ethics committee submission requirements), site initiation coordination, tracking enrollments, facilitating analyses, and reporting of results.
Proactively manage the Urology Clinical team for strategic analysis of study proposals, ongoing study updates and review of study data; track operational progress, budgets, and milestones for ongoing studies.
Triage study proposals for alignment with Long Range Plan, alignment of study design with study objectives, return on investment (ROI), ethical considerations, and assign to a study category (e.g., IIS, collaborative, third party request, PONDx, development); move proposal to appropriate teams for review.
Maintain a close collaboration with Data Management, Biostatistics, and Medical Communications regarding analysis of required support for study proposals, timelines for study completion to optimize the workflow for data analysis, and publication of study results.
Recruit, train, and support Clinical Affairs staff, which may include Clinical Study Managers, Clinical Research Associates, and Clinical Affairs Associates; support recruitment efforts for various Clinical Affairs positions.
Act as a customer advocate throughout the project lifecycle.
Ability to 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, such as 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 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 and FTE 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 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.
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.
Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
Communicate goals clearly to employees to ensure understanding and success in achieving them.
Motivate and inspire employees to do their best work through coaching.
Maintain morale and support employee engagement initiatives.
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 to a variety of problems of varying complexity.
Ability to manage multiple deadlines.
Excellent 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.
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 10% 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.
5+ years of experience in clinical research.
2+ years of experience managing direct reports or project team members in a clinical research environment.
2+ years of experience with CTMS, EDC, eTMF, and Sample management.
5+ years of experience in end-to-end trial activities; including feasibility, start-up, study conduct, close-out, data management, and report writing of clinical studies.
Demonstrated ability to write, review, and edit protocols and clinical study reports.
Strong knowledge of Good Clinical Practices and all applicable U.S. 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) preferred.
Experience in IVD studies and lab site management.
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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.
