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Pharmaceutical Clinical Trial Manager

DOCS Global


Location:
Durham, North Carolina
Date:
10/24/2017
2017-10-242017-11-23
Categories:
  • Clinical Operations
DOCS Global
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Job Details

 

We are looking for talented and motivated candidates to join the team and take part in this long term, dynamic project. The project will provide exposure across a variety of Therapeutic Areas with an organization that is on the forefront of adopting new processes and technologies, creating a unique opportunity for career growth and development.

Critical to the project is the role of Clinical Trial Manager will be responsible for leading the regional matrix team, including CRAs, CTAs and additional staff, to ensure delivery of country and site level study activities in alignment with the global study project plan.

 

Key Responsibilities include:

Identifying and resolving issues at a regional level

Collaborating with Global Project Manager 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

 

Requirements and Qualifications:

  • BA/BS/BSc or RN
  • Broad experience working in life sciences or medically related field
  • Previous management experience of direct reports
  • Experience in oversight of outside clinical research vendors including CROs, central labs, imaging vendors, etc.

 

Key Competencies:

Project Management / Risk Assessment / Critical Thinking and Planning / Matrix Team / Organizational Leadership / Metrics Analysis / Strong Written and Oral Communication / Delivery Focus / Decision Making / Relationship Management / Conflict Resolution / Problem Solving / Adaptability / Flexibility / Working in Virtual Teams

Flexible, adaptable and comfortable with change

Approachable and trustworthy

Builds constructive and effective relationships

Effective influencer and negotiator

Drives process improvement and technology adoption

Self-motivated, independent and proactive

Ability to identify risks and provide solutions – problem solving

Robust organizational, time management and prioritization skills

Experience in Risk Based Monitoring model

Attention to detail

Job Type: Full-time

Salary: $90,000.00 to $100,000.00 /year

 

Job Location:

Raleigh-Durham, NC

 

Required education:

Bachelor's

 

Required experience:

Pharmaceutical clinical trial management: 3 years

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