Manager, Clinical Affairs
Summary of Major Responsibilities
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 in-house Clinical Affairs staff.. The Clinical Affairs Manager 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, internally and externally, and provides professional development and guidance to assigned Clinical Affairs personnel. This position reports to of the VP, Clinical & Regulatory.
Essential Duties and Responsibilities
- Recruit, train, and support Clinical Affairs Associates;
- Work with Clinical Affairs leadership and Human Resources to establish a safe, secure, and legal work environment
- Develop personnel through open communication of job expectations, planning, monitoring, and providing feedback on assigned responsibilities
- Conduct regualar performance assessments and initiates career development discussions and planning for all direct reports
- Provides coaching, counseling, and disciplining of employees, when required, consistent with the core values of Exact Sciences
- Acts as a customer advocate throughout the project lifecycle.
- Understand and support project goals including site recruitment, patient recruitment, marketing and PR, as appropriate.
- Collaborates with Clinical Affairs leadership on the strategic direction of the Clinical Affairs organization
- Works with the Clinical Affairs leadership on resource planning and FTE allocation
- Develop and implement clinicals study processes to support study operations, staff training, and corporate business processes
- 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.
- 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).
- Develop and maintain project-specific tracking systems for study management and monitoring activities.
- 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.
Desired Education and Experience
- Four year degree.
- Minimum 5 years of experience in clinical research
- Minimum of 2 years of experience managing direct reports or project team members in a clinical research environment.
- Experience with CTMS, EDC, eTMF, LIMS, and Sample management
- Experience in IVD studies and lab site management
- Experience in end-to-end trial acitivities including feasibility, start-up, study conduct, close-out, 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).
Mandatory Skills and Qualifications
- 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.
- 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.
- 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.
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. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please call our Recruitment Coordinator at 608-535-8841 or email [email protected].
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