Ref #: 29291

Employment type: Permanent - Full-Time

Location: Russia / home based

Posted: 20-May-2021

Description

Key Purpose
• Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and applicable local regulations
• Maintain the quality and scientific integrity of clinical trials at a country level
• Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country

Key Activities
• Planning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)
• Accountable for study deliverables in that country.
• Leads country-level operational planning and supports site selection within region
• Ensure relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Ensure key stakeholders are kept informed of study progress e.g. GCTM, DOM
• Contribute to development of study-specific materials – e.g. monitoring plan, study specific training documents.
• Provides input into the Country Operational Plan (COP) and partner with the DFM and GCTM to ensure regional delivery of the Global Study Operational Plan (GSOP)
• Support and contribute to Trial Management Teams (TMTs), agenda driven presence at meetings and daily huddle as required
• Communicate country status (including timelines and deliverables) to key stakeholders (e.g. TMT, GCTM, Program Managers) and ensures updates to relevant systems
• Contributes to site-level goal setting and study-specific deliverables for clinical sites within their country
• Coordinates cross-functional review of issues escalated directly from sites or via the CRA and facilitates resolution
• Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
• Oversight and monitoring of applicable vendor activities eg. laboratories and equipment provisioning
• Monitor the execution of the clinical study against timelines, deliverables and budget for that country
• Monitor country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.
• Monitor and act upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate
• Monitor and review country/regional trends
• Review Monitoring Visit Reports
• Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across multiple countries, management of ELE process
• Identify and facilitate resolution of cross-functional study-specific issues
• Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
• Escalate any issues related to delivery, timelines or budget to GCTM or TMT lead if appropriate
• Execute regulatory agency inspection readiness activities (e.g. TMF review, story board generation)
• Participate in cross-functional task forces/process improvement groups
• Assign and oversee deliverables of study support staff e.g. Study Management Associate, CTS
• Member of the Global Clinical Studies Team (GCST)


Basic Qualifications
o Doctorate degree
o OR
o Master’s degree & 3 years of directly related experience
o OR
o Bachelor’s degree & 5 years of directly related experience
o OR
o Associate’s degree & 10 years of directly related experience
o OR
o High school diploma / GED & 12 years of directly related experience

Preferred Qualifications
• BA/BS/BSc
• 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)

Knowledge:
o Advanced knowledge of global clinical trial management
o Clinical trial processes and operations
o Extensive knowledge of ICH/GCP regulations and guidelines

Why Join DOCS?
If you are an experienced clinical study/trial manager, contact me now for more details with your latest CV at Orsolya.Berke@docsglobal.com



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