Regulatory And Start Up Specialist

hace 3 semanas

Madrid, España Precision Medicine Group A tiempo completo

Regulatory and Start Up Specialist - Clinical Trial Services Location: Madrid, Spain Job Type: Regular full-time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 4749
Precision for Medicine is not your typical CRO. 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/Senior Regulatory and Start Up Specialist to join our team in Spain . 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 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.
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 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, 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 the execution of investigator contracts.
May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
Keep an updated knowledge of the 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 for covering Belgium and the Netherlands.
Other Required: Strong communication and organizational skills.
Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
Fluency in English.
Preferred: Relevant regulatory and site start-up experience.
Experience using milestone tracking tools/systems.
Ability to prioritize workload to meet deadlines.
Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.
We invite you to learn more about our growing organization serving our clients researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for their contributions. You will provide input and have your ideas valued, impacting positive change for the company.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in your ability to access or use this online application process, you may contact Precision Medicine Group at ******.

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