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Local Clinical Project Manager

Employer
ICON Strategic Solutions
Location
Budapest, Hungary
Salary
Competitive
Start date
1 May 2022
Closing date
29 May 2022

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Job Details

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 Master's degree & 3 years of directly related experience
Preferred Qualifications
• BA/BS/BSc
must have project management experience in CRO PHARMA
• 7 years work experience in life sciences clinical research 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 and project management (e.g. CROs, central labs, imaging vendors, etc.)

Knowledge:
o Advanced knowledge of local clinical trial management
o Clinical trial processes and operations
o Extensive knowledge of ICH/GCP regulations and guidelines
o Project and Program management including oversight of study deliverable, budgets and timelines
o Time, cost and quality metrics, Key performance indicators (KPIs)
o Relevant Therapeutic knowledge
Competencies:
o Matrix team leadership
o Project Management
o Problem solving
o Decision making
o Delegation skills
o Relationship Management and influencing skills
o Oral and written communication
o Time management
o Business English
o Organizational and planning skills
o Ability to work effectively in a team/matrix environment on multiple projects

#PMjo

Company

As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.

ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.

Why choose a career with ICON Strategic Solutions?

Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.

Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.

Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.

Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.

Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.

Company info
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