Remote opportunity at
pfm medical, inc.Regulatory and Site Start Up Specialist
pfm medical, inc. is seeking a remote Regulatory and Site Start Up Specialist to join the organization. The company brings together operational scale, scientific expertise, and…
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About This Role
pfm medical, inc. is seeking a remote Regulatory and Site Start Up Specialist to join the organization. The company brings together operational scale, scientific expertise, and advanced data sciences to assist life sciences in accelerating the development of life-changing therapies, with a strong emphasis on oncology and rare diseases. In this full-time remote role, the professional will handle regulatory and site initiation activities, helping secure timely site activation readiness. This…
Job Description
pfm medical, inc. is seeking a remote Regulatory and Site Start Up Specialist to join the organization. The company brings together operational scale, scientific expertise, and advanced data sciences to assist life sciences in accelerating the development of life-changing therapies, with a strong emphasis on oncology and rare diseases. In this full-time remote role, the professional will handle regulatory and site initiation activities, helping secure timely site activation readiness.
This position suits an experienced professional with a background in regulatory affairs and site start-up processes within the clinical research or pharmaceutical sectors. Key duties involve managing submissions to Competent Authorities and Institutional Review Boards, gathering essential activation documents, customizing patient informed consent forms, and collaborating with internal teams like clinical operations and site contract management. The ideal candidate will maintain audit readiness, navigate local clinical trial laws, and manage project tracking tools to support successful clinical trial execution.
Precision Medicine Group operates as an equal opportunity employer. Candidates must hold legal authorization to work within their employment country without sponsorship. The employer does not request financial details during recruitment and advises applicants to report any fraudulent impersonation attempts.
Responsibilities
- Deliver site activation readiness on time and with high quality while mitigating risks within assigned locations
- Prepare and submit clinical trial applications, amendments, and notifications to Competent Authorities and Ethics Committees
- Handle communication and responses with regulatory bodies and ethics committees
- Provide regular submission updates to the Start Up Lead, Regulatory Lead, and Project Manager
- Maintain project plans, trackers, and regulatory intelligence tools
- Prepare study-specific start-up plans, IMP release requirements, and essential document review criteria
- Partner with assigned site CRAs to align communication and secure site collaboration
- Review, manage, and collect essential documents required for site activation and IMP release
- Customize country and site specific Patient Information Sheets and Informed Consent Forms
- Coordinate document translations required for submissions
- Communicate with feasibility, clinical operations, project management, and site contract groups
- Act as a subject matter expert for site-level critical path to site activation data points
- Participate in study budget negotiations and investigator contract execution under direction
- Support the feasibility group in site outreach to assess investigator interest
- Distribute knowledge of local clinical trial laws and regulations internally
- Maintain audit and inspection readiness and file documents in the Trial Master File
- Support pre-study site visits, process improvement initiatives, training, and mentoring
Requirements
- One year or more of experience as a Regulatory or Site Start Up specialist or comparable role in a CRO, pharmaceutical, or biotech industry
- Strong communication and organizational skills
- Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail
- Fluency in English and the local language of the employment country
- Legal authorization to work in the country of employment without employer sponsorship
Qualifications
- Bachelor’s degree in life sciences, scientific or healthcare discipline, Registered Nurse, or equivalent education, training, and experience
- Relevant regulatory and site start-up experience for the specific country
- Experience using milestone tracking tools and systems
- Ability to prioritize workload to meet deadlines
- Advanced degree in medical or life sciences such as MD, PhD, or PharmD
- RAC certification
- Master’s degree in Regulatory Science
Core Skills
Frequently Asked Questions
What is the location and remote status of this job?
The position is fully remote.
What is the employment type?
The role is full-time.
What salary does this position offer?
The posting does not specify the salary.
Are there specific education requirements for applicants?
Applicants must have a bachelor's degree in life sciences or a related scientific/healthcare field, be a Registered Nurse, or possess an equivalent combination of education, training, and experience.
Do candidates require work authorization sponsorship?
Candidates must be legally authorized to work in the country of employment without employer sponsorship.
Sample Interview Questions
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