Regulatory and Start Up Specialist

Regulatory and Start Up Specialist – Clinical Trial Services

Location: Berlin, Germany

Job Type: Regular Full-time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 4803

Precision for Medicine is not your typical CRO. At Precision for Medicine, we have brought together new technologies, expertise, and operational scale to help the life sciences improve the speed, cost, and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.

As our organization continues to grow, we are hiring a Regulatory and Start Up Specialist to join our team in Germany . This position can be offered fully home-based.

Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs, and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team.
• Maintenance of project plans, project trackers, and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership informed.
• Preparation/Support the development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage the collection of essential documents required for site activation/IMP release.
• Customize country/site-specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and coordination of translations for documents.
• Maintain communication with other key functions participating in country start-up, e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project-specific status and deliverables.
• Act as SME for collection and maintenance of site-level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts, and budget negotiation requirements for and other required reviews to secure on-time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under the direction of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators in a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distribute their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study-specific plans in the relevant TMF.
• May support the clinical team performing Pre-Study Site Visits.

Experience / Qualifications

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Regulatory/SU experience in covering DACH region (Germany, Austria, Switzerland).

Other Required:

• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail required.
• Fluency in English and for non-English speaking countries, the local language of the country where the position is based.

We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

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