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.
We have a strong focus on Oncology and Rare Disease.
Due to our continued growth we are seeking a Regulatory and Site Start Up Specialist.
The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities.
The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines.
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.