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Study Start-up Specialist

  • Location:

    Walloon Brabant, Belgium

  • Contact:

    Aurore Munaut

  • Job type:

    Permanent

  • Contact phone:

    +32(0)2 588 16 01

  • Industry:

    Pharmaceutical

  • Contact email:

    Aurore_Munaut@oxfordcorp.com

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!"

Job description

  • 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.

Responsibilities

  • 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.





Profile

  • 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 ).

Benefits

  • 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