Do you have experience in Study Start-up activities or experience in Submissions? Are you fluent in ENG and NL? And you're located in Belgium (Walloon Brabant) or in The Netherlands? Then we have your dream job!"
- Responsible for activities related to study start up and ongoing study document management.
- Act as point of contact for local study teams and external stakeholders.
- Independently manages multiple country, study and site level deliverables during start-up and maintenance both within the company and external business partners and vendors, when required.
- Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones.
- Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
- Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
- Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
- Collaborates with other internal roles in country feasibility and site selection.
- Collaborates directly with the internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines.
- Prepare country Informed Consent Form (ICF) and manage country ICF template.
- Review and approval of Site ICFs.
- Review and approval of Clinical Trial Package (CTP) documentation.
- Update national registries as applicable.
- Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management.
- When applicable, conduct drug/IMP label review & translation.
- Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal.
- May support the collection and distribution of documents from / to sites including obtaining insurance certificates.
- May support Health Authority inspection and pre-inspection activities.
- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.
- Serves as an SME for key investigational sites. Documents and maintains relevant information on the site's structure, start-up processes, key contacts, etc (i.e., Site Playbook) for sharing with internal team members.
- Represents the company in local (e.g. pharma association or HA driven) working groups around start up processes in the country.
- Represents the company in meetings discussing local requirements / repetitive questions from local Health Authority and Ethics Committees.
- Proactively works with stakeholders (e.g. document template owners, GRS, CMC, CSO) to prevent questions from HA based on observed past questions.
- Constantly analyse the SSU process, looking for innovative ways to introduce efficiencies in order to speed-up start-up timelines, whilst maintaining quality.
- Bachelor's or Master's Degree within life sciences or equivalent.
- Thorough understanding of GCP, ICH Guidelines and Country regulatory environment.
- In depth knowledge and understanding of clinical research processes, regulations and methodology.
- Demonstrated organizational and planning skills and independent decision-making ability.
- Strong organization and time management skills and ability to effectively manage multiple competing priorities.
- Ability of critical thinking and risk analysis.
- Good verbal and written communication skills (both in English and local language).
- Microsoft Suite.
- Clinical Trial Management Systems (CTMS).
- Electronic Trial Master File (eTMF).
- Document exchange portals.
- Existing right to work in Europe required ( please read job spec in full before applying ).
- A balanced salary package based on your capabilities and experience, including meal vouchers, hospitalization and groups insurance, mobile phone, FIP-plan, etc ...
Vacancy number : 18259