Site Start Up Associate II / Senior Site Start Up Associate - Spain
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 analgesia, neuroscience, oncology, pediatrics, and rare diseases.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact.
You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
We’re looking for a talented and energetic Site Start Up Associate II / Senior Site Start Up Associate to join our team in Spain! This is a permanent role which will ideally be located in our office in Madrid, Spain. However, we are open to considering home based working too.
You'll be accountable for:
- Taking responsibility for quality deliverables at the country level for site start-up in one or more components.
- Proactively forecasting submission/approval timelines and ensuring they are adhered to. If forecasted timelines are not reached, providing clear rationale for delays, providing contingency plan to mitigate impact, and escalating 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.
- Preparing and submitting Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Preparing ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules.
- Submitting end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities in the specified country according to national timelines.
- Performing 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 - producing site-specific contracts from country template. Submitting proposed contract and budget for site. Negotiating budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
- Preparing checklist for IP release according to country regulations.
- Ensuring 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.
- Collecting information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
- Liaising with internal team members to review areas that impact study start-up and shares start-up information with the project team.
- Providing country-level intelligence on site start-up. Ensuring that local country regulatory intelligence is maintained on the central repository, e.g. Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.
- Setting up and maintaining a country folder with country Ethics Committees/Review Board and local authority addresses and requirements.
- Pending country in use, the SSUA may set up and maintain details of existing site and institution contract requirements, as well as the necessary templates and fees, on the clinical trial application database on SharePoint.
- Providing quality review of the informed consent and adapts the template as appropriate.
- Working within the scope of Clinical Management Plan (CMP), study processes, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
- Ensuring 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.
- Providing training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.
- Reviewing 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.
- Providing data protection compliance guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This will typically include the Principal Investigator/Informed Consent and the CDA/contract template.
- Mentoring and training junior level staff.
You’ll need this to be considered
- Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions
- Prior experience in the submission of clinical trial applications to EC and RA
- Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the specific Spanish regulatory requirements for conducting clinical trials.
- Knowledge of site and institution specific contract requirements
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job
- Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site Start-Up activities will be carried out
- Experience in adapting documents as per local regulations
- Experience in IDP checklist/packages for IP release
- Proficient in the development and review of Informed Consent Form templates
- May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents
- Ability to interact with site, clients, vendors and other functional areas as secondary project contact for site issues and questions
- Ability to manage time and project requirements based on study contract
- Ability to travel up to 10%
We are looking for these soft skills:
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Accountable, dependable and strong commitment
- Is customer-service focused in approach to work, both internally and externally
- Maintains a positive, results orientated work environment
- 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
You must be eligible to live and work in Spain in order to apply for this role