Regulatory and Start Up Specialist / Contracts and Budget Specialist

Precision for Medicine; Cádiz; Presencial; EUR 30.000 - 60.000; Jornada completa

Descripción de la vacante

An innovative organization is seeking a Regulatory and Start Up Specialist to enhance the speed and success of clinical trials. This role involves ensuring site activation readiness, managing project plans, and collaborating with various teams. Ideal candidates will have a background in life sciences and experience in regulatory processes. Join a forward-thinking company that values employee contributions and fosters a supportive work environment, where your ideas can lead to impactful change in the life sciences industry. This position offers the flexibility of being fully home-based, allowing you to work in a way that suits your lifestyle.

Formación

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

Responsabilidades

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

Conocimientos

Communication Skills

Organizational Skills

Negotiation Skills

Fluency in English

Fluency in Spanish

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

Milestone Tracking Tools

Descripción del empleo

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:

1. Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
2. Maintenance of project plans and project trackers.
3. 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.
4. Act as SME for collection and maintenance of site level critical path to Site Activation data points, including site contracts and budget negotiation requirements.
5. 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

Minimum Required:

1. 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.
2. 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.
3. Experience drafting, reviewing and negotiating agreements related to clinical research.
4. Experience developing and negotiating the budget.

Other Required:

1. Strong communication and organizational skills.
2. Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
3. Fluency in English and Spanish.

Preferred:

1. Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience.
2. Experience using milestone tracking tools/systems.
3. Ability to prioritize workload to meet deadlines.
4. 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.