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Precision Medicine GroupRegulatory and Site Start Up Specialist
Precision Medicine Group is expanding its team and seeking a Regulatory and Site Start Up Specialist to contribute to oncology and rare disease clinical trials. The…
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About This Role
Precision Medicine Group is expanding its team and seeking a Regulatory and Site Start Up Specialist to contribute to oncology and rare disease clinical trials. The company merges operational scale, deep scientific insight, advanced data analytics, and laboratory capabilities to help life sciences organizations accelerate the delivery of novel therapies to patients. This professional handles crucial clinical trial preparation tasks, including regulatory submissions, essential document collection, and site activation tracking.…
Job Description
Precision Medicine Group is expanding its team and seeking a Regulatory and Site Start Up Specialist to contribute to oncology and rare disease clinical trials. The company merges operational scale, deep scientific insight, advanced data analytics, and laboratory capabilities to help life sciences organizations accelerate the delivery of novel therapies to patients. This professional handles crucial clinical trial preparation tasks, including regulatory submissions, essential document collection, and site activation tracking.
The person in this role will prepare and submit documentation to Ethics Committees, Institutional Review Boards, and Competent Authorities while adhering to internal procedures and international standards. Key duties involve managing communications with regulatory bodies, adapting informed consent forms, partnering with clinical research associates, and assisting the site contract group with budgets and agreements. Candidates should possess experience in site start-up operations, strong organizational skills, and a solid understanding of local clinical trial regulations.
Responsibilities
- Deliver site activation readiness for assigned locations on schedule while managing risks
- Prepare clinical trial application dossiers and amendments for regulatory authorities and ethics committees
- Handle responses and maintain regular communication with competent authorities and review boards
- Maintain project plans, trackers, and regulatory intelligence tools
- Review, collect, and manage essential documents needed for site activation and investigational medicinal product release
- Customize and translate patient information sheets and informed consent forms
- Act as a subject matter expert for site-level critical path data and in-country team support
- Assist with study budget negotiations and investigator contract execution under direction
- Support pre-study site visits, process improvement initiatives, and mentoring
Requirements
- Bachelor degree in a life sciences, healthcare, or related field, or qualification as a Registered Nurse or equivalent combination of education, training, and experience
- Minimum of one year of experience as a regulatory or site start-up specialist, or comparable role within the pharmaceutical, biotechnology, or contract research organization industry
- Strong communication and organizational skills
- Proficiency in utilizing computerized information systems, electronic spreadsheets, word processing, and email
- Fluency in English alongside the local language of the employment country where applicable
- Legal authorization to work in the employment country without requiring employer sponsorship
Qualifications
- Specific regulatory and site start-up experience in the assigned country, covering feasibility, contract negotiations, and committee submissions
- Prior use of milestone tracking systems and tools
- Advanced degree such as an MD, PhD, or PharmD, or a Master in Regulatory Science
- Regulatory Affairs Certification
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the employment type for this role?
The posting indicates that this is a full-time position.
What remote work options are available?
The source posting states the role is on-site, though a specific city or office location is not provided.
What salary is offered for this position?
The source posting does not specify a salary.
What education or background is required?
Candidates must hold a bachelor degree in life sciences or a related healthcare field, be a Registered Nurse, or have an equivalent combination of education, training, and experience.
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