Ref #: 29255

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 20-May-2021

Description

Key responsibilities :

• 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
• 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)



Required experience and qualifications :

• Academic degree (Life Sciences)
• 7 years of work experience in life sciences or medically related field, including 3 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.)
• Advanced knowledge of global clinical trial management
• Clinical trial processes and operations
• Extensive knowledge of ICH/GCP regulations and guidelines
• Project and Program management including oversight of study deliverable, budgets and timelines
• Time, cost and quality metrics, Key performance indicators (KPIs)
• Relevant Therapeutic knowledge
• Fluent communication skills in Dutch & English




Why this role is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a companies dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.



Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.



Interested? Please submit your CV via www.docsglobal.com, or ken.falorni@docsglobal.com