Covance is looking for a Senior SSU & Regulatory Specislist to work 100% dedicated to one of our clients which is a leading pharmaceutical company.
Check out the role responsibilities and requirements below :
The Senior SSU & Regulatory Specislist is accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH / GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
Through continual interaction with local clinical team / s successfully delivers clinical and financial contracts within fair market value.
Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out.
Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD.
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.
LOCAL PROCESS OVERSIGHT :
Oversight and coordination of local processes.
Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic / hard copy filing, archiving and retention requirements, and insurance process management.
Enters and updates country information in clinical, regulatory, safety and finance systems.
Problem solving and Process Improvement is essential to this position. Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable.
Specific examples of common problems include : 1)
Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol
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 verba
Minimum of four-six (4-6) years of clinical research experience within the Study Start-Up area looking after Submissions to the LA and EC, protocol amendments, contracts and contract negotiation.
Job Number 2018-21878
Job Category Clinical Operations
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority / Female / Individual with Disability / Veteran / Sexual Orientation / Gender Identity).
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