Remote Regulatory Start-Up Specialist - Spain CRO — Columbus

Precision for Medicine is a global Clinical Research Organization with a uniquely integrated offering that enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and a real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Due to our continued growth, we are seeking a Regulatory and Start Up Specialist based in Spain to join our growing team. Apart from experience with regulatory submissions, this role requires candidates to have contracts and budgeting negotiation experience for Spain.

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 assigned country/sites, foreseeing and mitigating any risks.

• Preparation of Clinical Trial Application Forms as well as submission dossiers (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of Clinical Trials, in accordance with international and local/national applicable regulations, company SOPs, and principles of ICH-GCP.
• 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 the Project Manager/Project Team.
• Maintenance of project plans, project trackers, and regulatory intelligence tools as they pertain to assigned responsibilities, and keeping Regulatory Leadership informed.
• Preparation/support of the development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
• Partnering with the assigned site CRA to ensure alignment in communication and secure site activation.
• Review and manage the collection of essential documents required for site activation/IMP release.
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms.
• Responsible for facilitating the translation and coordination of translations for documents.
• 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.
• Act as SME for the collection and maintenance of site-level critical path to Site Activation data points, including Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts, and budget negotiation requirements to secure on-time site activation for assigned sites in the country.
• When required, participate in/support the negotiation of study budgets and the execution of investigator contracts under the direction of the Site Contract Management department.
• May participate in/support the feasibility group in site outreach to assess potential interest of investigators in a potential study.
• Keep updated knowledge of local clinical trial laws and regulations, and help distribute that knowledge within PFM to ensure conduct of Clinical Trials according to applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study-specific plans in the relevant TMF.
• May support the clinical team in performing Pre-Study Site Visits.

The Ideal Candidate Will Have:

Minimum Required:

• Bachelor's degree in life sciences or a related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN), or equivalent combination of education, training, and experience.
• A qualification in Pharmacy or work experience as a Pharmacist would be highly beneficial.
• Demonstrated experience in contracts and budgeting negotiation.

Other Required:

• Previous experience working as a Regulatory or Start Up Specialist in a CRO, pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
• Fluency in English and Spanish; fluency in Portuguese would be a strong plus.

Preferred:

• Relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions).
• 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, or Masters in Regulatory Science.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are unable to access or use this online application process, you may contact Precision Medicine Group at [email protected].

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Candidates must be legally authorized to work in the country of employment without employer sponsorship.