- 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.
- BA/BS/RN/BSN or equivalent is preferred with 8+ years of biotech clinical research experience, or an equivalent combination of education and experience
- 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.
- 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.
- A collaborative teamwork environment where learning is constant, and performance is rewarded.
- The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
- A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
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Manager, Clinical Programs - Myrtle Point, United States - Knewin
Description
Req#: 36aa5f4a-1ed eb-347cfGeneral Summary
The 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
Position Qualifications
Minimum education and experience:
Additional qualifications:
Annual Base Salary Range:
$126,180- $187,106
This 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.
What We Offer
Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need.
Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets.
The Penumbra logo is a trademark of Penumbra, Inc.Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer toPenumbra's Privacy Notice for California Residents.
For additional information on Penumbra's commitment to being an equal opportunity employer, please
Penumbra's AAP Policy Statement.
Penumbra, Inc. is a global healthcare company focused on innovative therapies that address challenging medical conditions and significant clinical needs.
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