Site Start Up Associate (II or Sr) - Czech Republic
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Site Start-Up Associate to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
We're looking for a talented and energetic Site Start-Up Associate II/Senior to join our team in Czech Republic!
The Site Start-Up Associate:
- 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 Lead and Regulatory Start-up Lead (or designee) during start-up on allocated projects.
- Prepares and submits initial clinical trial applications, substantial amendments, ongoing notifications to Central EC, Local EC, Competent Authority and other local regulatory authorities as required.
- 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.
- Prepares checklist for IP release according to country regulations.
- 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.
- Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team.
- Provides quality review of the Informed Consent and adapts the template as appropriate.
- Works within the scope of Regulatory & Start-Up Submission Plan (RSSP), study processes & SOPs, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
- 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.
- Provides training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.
- Reviews and advises on SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.
- Mentors and trains junior level staff.
- Other activities as designated.
You'll need this background to be considered:
- Undergraduate degree in a clinical, science, health or legal related field.
- 3+ years of related experience, including minimum 1.5 - 2 years of experience in performing submissions of clinical trials in Czech Republic.
- Expertise in ICH/GCP requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials.
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job.
- Strong verbal and written communication and negotiation skills.
- Ability to read, write, and speak fluent English.
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment.
- Excellent team player, maintaining a positive, results orientated work environment.
- Has proven experience working with internal and external customers/vendors to meet project specific goals.
- Maintains a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach.