Job Overview :
Covance is looking for a study start up specialist to work 100% dedicated to one of our clients, a leading pharmaceutical company.
Office based in Lucern.
You will be responsible for Project Managing the submissions part of start-up activities for studies within Switzerland.
This role could suit a CRA or Senior CRA looking for less travel or an experienced Study Start-Up specialist looking to move into a more junior project management role
Check out the role responsibilities and requirements below :
COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS :
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
Development of local language materials including local language Informed Consents and translations.
Works in partnership with IRB / IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
MANAGEMENT & QUALITY OVERSIGHT :
Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
Responsible for quality and compliance in assigned protocols in the country. Contributes to the development of
local SOPs. May oversee contract workers (CTCs) and local vendors as applicable.
COLLABORATION : Works in close collaboration internally with GCTO country operations (CRM,CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations, HQ functional areas and externally with vendors and sites, IRB / IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
We need someone who is fluent in ENGLISH and also ideally in GERMAN.
French or Italian langauge skills would also be needed!
Education / Qualifications :
University / college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
Thorough understanding of the drug development process
Fluent in local office language and in English, both written and verbal
Minimum of four-six (4-6) years of clinical research experience within the Study Start-Up area looking after Submissions to local authorities, protocol amendments, contracts and contract negotiation.