Regulatory and Start Up Specialist/Contracts and Budget Specialist Remote, Spain

Precisionscientia; Maryland; Remote; USD 80,000 - 100,000; Full time

Job summary

An innovative organization is seeking a Regulatory and Start Up Specialist to enhance site activation processes for clinical trials. This remote role involves ensuring readiness through effective project management and communication with cross-functional teams. You will leverage your expertise in regulatory affairs, contract negotiations, and budget management to drive success in groundbreaking cancer research initiatives. Join a forward-thinking company that values your contributions and fosters a collaborative environment where your ideas can lead to impactful changes in the life sciences sector. This is a unique opportunity to be part of a team dedicated to improving patient outcomes through advanced therapies.

Qualifications

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

Responsibilities

• Ensure timely and quality site activation readiness for clinical trials.
• Maintain communication with key functions on project status and deliverables.

Skills

Communication Skills

Organizational Skills

Negotiation Skills

Fluency in English

Fluency in Spanish

Education

Bachelor’s degree in life sciences

Registered Nurse (RN)

Advanced degree in medical or life sciences

Tools

Computerized information systems

Electronic spreadsheets

Word processing software

Milestone tracking tools/systems

Job description

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:

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 to 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

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 groundbreaking 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.