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. We integrate clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to help life sciences improve the speed, cost, and success rate of bringing life-changing therapies to patients.
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 and submission dossiers (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines.
* Interaction with CA/EC for study purposes and handling responses.
* 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.
* Preparation/support 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 management 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 key functions participating in country start-up, including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group.
* Act as SME for collection and maintenance of site-level critical path to Site Activation data points.
* When required, participate/support the negotiation of study budgets and execution of investigator contracts.
* May participate/support feasibility group in site outreach to assess potential interest of investigators.
* Keep updated knowledge of local clinical trial laws and regulations.
* Maintain audit/inspection readiness at all times and file documents as per TMF plan.
* May support the clinical team performing Pre-Study Site Visits.
Experience / Qualifications
* Bachelor’s degree in life sciences or related field, 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.
* 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.
* Fluency in English and local language of the country where the position is based.
We invite you to learn more about our growing organization serving clients researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for their contributions.
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