Clinical Field Manager
Job Summary
Job Description
The Clinical Field Manager manages a field support team, collaborating with Clinical Project Managers on clinical trials. Responsibilities include supervising and training CRAs, developing study materials, improving processes, troubleshooting compliance issues, reviewing monitoring reports, overseeing site adherence to regulations, reviewing clinical documents, participating in vendor selection, and ensuring QMS compliance. The role requires strong people and project management skills, knowledge of ICH-GCPs and 21 CFR, and experience in managing Phase 1-3 clinical studies. This remote US-based position requires eligibility to work in the US without restriction.
Must have:
- 8+ years clinical/scientific research experience
- Supervisory experience
- ICH-GCP and 21 CFR knowledge
- Vendor management
- Project management skills
Good to have:
- Medical device experience
- ISO 14155 and MDR 2017/745 knowledge
Perks:
- Competitive compensation package
- Benefits (medical, dental, vision)
- 401k with employer match
- Employee stock purchase plan
- Paid parental leave
- Paid holidays and vacation
8 skills required
Job Details
General Summary
The Clinical Field Manager manages the field support team and works alongside the Clinical Project Managers to support the respective clinical trials. May manage CROs or external vendors. Develops and applies best practices in the development, initiation, planning, execution, control and closing of projects. Actively participates in cross functional project teams representing clinical operations from both a strategic and tactical perspective. The Clinical Field Manager will be based in their remote US home office. Unfortunately, sponsorship is not available for this opportunity, so you must be eligible to work in the United States without restriction.
Specific Duties and Responsibilities
* Supervise, train, coach, develop, and evaluate Clinical Research Associates. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.*
* Collaborate with Clinical Project Managers on development of study start up materials, informed consent templates, and study manuals.*
* Contribute to the improvement of processes, systems, tools, and procedures. May contribute to SOP/WI review and development. Ensures compliance across studies.*
* Troubleshoot with team members on site compliance and improvement plans.*
* Oversee completion and review of monitoring reports, ensuring accuracy and timely reporting for team members.*
* Attend monitoring visits with team members as needed to ensure consistency in the field.*
* Oversee investigative sites' adherence to regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and Clinical Research Organization (CRO) team members.*
* Review clinical documents (i.e. protocols, amendments, clinical study reports) and clinical sections of regulatory documents (i.e. IND annual reports, annual or periodic safety reports, IND and NDA filings) for accuracy, consistency and quality.*
* Participate in assessment and selection of Contract Research Organizations (CROs), sites, and other vendors. May perform qualification visits as needed, solicit and review proposals, review or negotiate budget and Scope of Work.*
* 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:
* Bachelor’s degree in Biological sciences or a health-related field (e.g., Biology, Chemistry, Biochemistry, Nursing, Biomedical or Veterinary Sciences) preferred with 8+ years of experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry required, or an equivalent combination of education experience
Additional qualifications:
* Clinical research experience in the pharmaceutical or biotechnology industry required; medical device experience preferred
* Experience in the operational aspects of managing phase 1-3 clinical studies from start-up to closeout, vendor management, and planning cross-functional operational activities
* Knowledge of ICH-GCPs and 21 CFR is required, along with extensive clinical research knowledge and cross-functional understanding of clinical trial methodology. ISO 14155 and MDR 2017/745 knowledge is preferred
* Extensive people management and project management skills required
* 1-3+ years of experience in a supervisory role preferred
* High degree of accuracy and attention to detail
* Strong oral, written, and interpersonal communication skills
* Proficiency with MS Word, Excel, and PowerPoint
* Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
Working Conditions
* General office environment
* Travel up to 30% of the time
* Potential exposure to blood borne pathogens, radiation and other potentially infectious materials
* Requires some lifting and moving of up to 10 pounds
* Willingness and ability to work on site
* 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: $126,280 - $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
•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).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. 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 to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
What We Offer
•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).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. 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 to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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