Manager, Clinical Programs

General SummaryThe Manager, Clinical Programs (MCP) is responsible for the execution of a suite of clinical trials and provides leadership and manages the study managers who drive trial execution. Responsibilities include creating timelines with cross functional teams, study document creation, start up and study close out. Will work with a wide variety of vendors. A MCP mentors the study managers while they coordinate across other functional groups that comprise the clinical department; specifically, statistics, clinical monitoring, data management, medical writing, medical and safety to insure proper conduct and timely completion of all projects. This role ensures consistency on the execution of trials throughout the department.

Specific Duties and Responsibilities•Responsible and accountable for global clinical studies as part of a therapeutic program, inclusive of strategy.•Develops strong and collaborative working relationships with Key Opinion Leaders.•Hire, train and mentor study managers to develop project plans inclusive of database planning, enrollment projection, site ramp up through database lock and trial completion. Manage all aspects proactively.* •Develops staffing plans for onboarding and continuing career growth.•Oversees the timelines of data snapshots for study reports, DSMB and CEC meetings and FDA submissions.•Responsible for overseeing MS Project timelines for each project and uses these timelines to track and manage a project's progress. Ensures resources are available across projects.•Reviews and approves Penumbra marketing materials.•Participates in cross functional strategy plans with internal (Regulatory Affairs, Marketing, Reimbursement, R&D) and external (Key Opinion Leaders, Study Investigators, etc.) stakeholders to draft global clinical strategies. •Reviews and/or writes protocols and assists in CRFs development.•Manages and oversees data review, participates in safety review.•Collaborates with Medical Affairs and Marketing for clinical podium publications and presentations as needed globally.•Proactively looks for process improvements opportunities in the department and implements them.•Leads team in vendor selection and ensures strong relationships with those vendors (e.g. Core Lab, EDC, and CROs).•Participates in internal/external audit as the subject matter expert.•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * •Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * •Ensure other members of the department follow the QMS, regulations, standards, and procedures. * •Perform other work-related duties as assigned. *Indicates an essential function of the role

*Position Qualifications***Minimum education and experience:•BA/BS/RN/BSN or equivalent is preferred with 8+ years of biotech clinical research experience, or an equivalent combination of education and experience

*Additional qualifications:** •Highly effective organizational and communication skills.•High degree of accuracy and attention to detail.•Previous Field monitoring experience highly desirable.•Previous FDA or other regulatory body trial design experience preferred.•Medical device, pharmaceutical, biotech, or other regulated industry experience desired.•Knowledge of CFR and GCP/ICH requirements is required.•Demonstrated leadership skills and the ability to solve problems proactively.•Proficiency with Excel, MS Project, Contract development and vendor oversight. CRO management experience a plus.•Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term objectives of the Company.

Working Conditions•General office environment.•Potential exposure to blood-borne pathogens.•Approximately 15% travel.·Willingness and ability to work on site. ·Requires some lifting and moving of up to 15 pounds.·Must be able to move between buildings and floors. ·Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. ·Must be able to read, prepare emails, and produce documents and spreadsheets.·Must be able to move within the office and access file cabinets or supplies, as needed. ·Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Annual Base Salary Range: $126,180- $187,106This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.