Study Start-Up Associate /Senior - Belgium (Remote)
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 Study Start-Up Associate II/Senior to join our team in Belgium.
Your main responsibilities:
- 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
- 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, and other local regulatory authorities as needed within the country
- Performs essential document collection and review
- 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.
- Ensures documentation of QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.
- May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
- 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.
- Undergraduate degree or its international equivalent in a clinical, science
- Min. 1 year of professional experience in preparing submissions
- Thorough knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations
- Good knowledge of the relevant country specific regulatory requirements for conducting clinical trials
- Fluency in English and local language
- Maintains a positive, results orientated work environment
- Excellent team player, collaborative and able to build an effective team
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Strong verbal and written communication and negotiation skills