Site Start-Up Associate /Senior - Remote, Netherlands
Bring your Passion to Premier!
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We're looking for a talented and energetic Site Start-Up Associate II/Senior to join our team!
- Takes responsibility for quality deliverables at the country level for site start-up in one or more components.
- Follows project requirements and applicable country rules.
- Proactively forecasts submission/approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified
- Local Clinical Trial Applications Specialist - may serve as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects.
- Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA.
- Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Local Investigator Contract and budget negotiator - produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
- Ensures accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF.
- Provides all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up.
- Collects information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
- Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team.
- Works within the scope of Clinical Management Plan (CMP), study processes, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
- Provides training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.
- Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.
- Mentors and trains junior level staff.
- 1 – 2 years of related experience (health sciences, biology degree)
- Prior experience using computerized information systems preferred
- Ability to read, write, and speak fluent English; fluent in host country language
- Clinical trials support or pharmaceutical industry experience preferred
- Office based or clinical employment experience preferred
- Successful experience and results at Level 1
- At least 2 years’ experience in the submission of clinical trial applications.
- Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical
- Knowledge of site and institution specific contract requirements
- Clinical trials support or pharmaceutical industry experience required
- Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body
Level 3 (Senior)
- Same Accountabilities as Level 1 & 2
- 3+ years of related experience
- Serves as primary liaison for country study start-up and site start-up management issues
EDUCATION, SKILLS & COMPETENCIES:
Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
Expertise and know-how
- Thorough knowledge of ICH/GCP regulations required
- Working knowledge of FDA Guidance Documents / EU Directives & Regulations / Local Regulations / ISO14155 regulations for drug / device development procedures
Personal skills & behaviors
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions
- Excellent team player, collaborative and able to build an effective team
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Strong verbal and written communication and negotiation skills
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Accountable, dependable and strong commitment
- Maintains a positive, results orientated work environment