Ref #: 24376

Employment type: Permanent - Full-Time

Location: US - Remote - West Coast

Posted: 19-Oct-2020

Description

DOCS is currently seeking an experienced Regional Clinical Trial Manager, remote home based in the US.

Key Responsibilities

• Leading the regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan
• Identifying and resolving issues at a regional level
• Collaborating with Global CTM to ensure country level study delivery is aligned with the global study project plan
• Contributing to study-level risk assessments
• Leading and continually review regional risk mitigation activities to ensure study delivery to plan
• Overseeing regional insourcing/outsourcing partner deliverables to the required standards Partnering with Tech Services, Supplier Governance and Electronic Trial Operations - to ensure regional, country and site vendor set-up, conduct and quality Leading regional documentation and required tool and systems set-up
• Contributing to regional aspects of Drug Supply Plan
• Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines

Basic Qualifications

• BA/BS/BSc or RN
• Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)

Preferred Qualifications

• BA/BS/BSc in the sciences or RN
• Previous management experience of direct reports
• Experience in oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)

Knowledge

• Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines
• Clinical Development process and procedures
• Project planning experience including oversight of study deliverables, budgets, and timelines
• Ability to use scientific and clinical knowledge to conceptualize study designs
• Experience anticipating and resolving problems
• Experience writing and presenting clearly on scientific and clinical issues
• Experience collaborating and leading cross-functional teams (team/matrix environment)
• Knowledge of project risk management assessment and mitigation approaches

Key Competencies

• Project Management
• Risk assessment
• Critical Thinking and Planning
• Matrix Team organization/leadership
• Metrics analysis
• Written and oral communication
• Delivery focus
• Decision Making
• Problem solving
• Relationship management
• Conflict resolution
• Adaptability and Flexibility
• Working in virtual teams