Regulatory and Start Up Specialist / Contracts and Budget Specialist

Precision Medicine Group; Granada; A distancia; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

An innovative firm is seeking a Regulatory and Start Up Specialist to enhance the efficiency of clinical trials. This role involves ensuring timely site activation, maintaining project plans, and facilitating communication among key stakeholders. The ideal candidate will possess a strong background in regulatory affairs and budget negotiation, with a commitment to improving the delivery of life-changing therapies. Join a dynamic team where your contributions are valued, and help shape the future of healthcare by supporting groundbreaking cancer research.

Formación

• 1+ years as a Regulatory/SU specialist in CRO or biotech.
• Experience drafting and negotiating clinical research agreements.

Responsabilidades

• Ensure site activation readiness and mitigate risks.
• Maintain project plans and communication with key functions.

Conocimientos

Regulatory Affairs

Budget Negotiation

Communication Skills

Organizational Skills

Clinical Research Agreements

Educación

Bachelor's degree in Life Sciences

Registered Nurse (RN)

Advanced Degree in Medical or Life Sciences

Herramientas

Computerized Information Systems

Electronic Spreadsheets

Word Processing Software

Descripción del empleo

Regulatory and Start Up Specialist / Contracts and Budget Specialist

Remote, Spain

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 organisation continues to grow we are hiring a Regulatory and Start Up Specialist / Contracts and Budget 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.
• Maintenance of project plans and project trackers.
• Maintain communication with other key functions participating to 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 site contracts and budget negotiation requirements.
• When required, participate / support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department / designee department.

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 / SU specialist (or comparable role) in either a CRO or pharmaceutical / biotech industry or equivalent, relevant experience and / or demonstrated competencies.
• Experience drafting, reviewing and negotiating agreements related to clinical research.
• Experience developing and negotiating the budget.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and Spanish.

Preferred :

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA / EC / IRB submissions) 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 that are researching ground breaking 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.