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DOCS Regional Clinical Trial Manager in Helena, Montana

Regional Clinical Trial Manager

Ref #: 31770

Employment type: Permanent - Full-Time

Location: US - remote

Posted: 30-Jul-2021

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

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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