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DOCS Clinical Study Planning Manager in Columbia, South Carolina

Clinical Study Planning Manager

Ref #: 25246

Employment type: Permanent - Full-Time

Location: US - Nationwide

Posted: 10-Jan-2021

Description

DOCS is search for Clinical Study Planning Managers in the United States. This is a home-based position.

Responsibilities:

Lead the development of realistic study timelines, from design through final study reporting • Maintaining accuracy of clinical study timeline information in data control systems (e.g., APECS) • Tracking, documenting and ensuring key stakeholder involvement and timely delivery of clinical study deliverables • Communicating information on clinical trial status, changes, and issues to stakeholders • Increasing the efficiency of trial operations through the sharing of cross-program knowledge and identification of best practices leading to standardization across the organization • Contributing to development of high performing study teams • Participating in (or leading) special projects as assigned • Adhering to all company policies, clinical development processes, SOPs, and clinical project management processes • Represent CSP group in applicable forums and lead functional specific communications Key Activities • Manage the development of and monitor the implementation of high-quality, realistic, cross-functional, global clinical trial timelines in Company's planning systems within specified deadlines • Conduct integrity checks and data issue resolution on a routine basis for assigned study timelines • Manage, implement and communicate changes per the Change Impact Assessment Review & Approval (CIARA) process or other mechanisms as appropriate • Ensure alignment of funding/investment of clinical studies within assigned programs to support operational planning by functions (ie, via monthly RAP, annual LRP, quarterly LE, etc.) • Stay abreast of latest developments in drug development and contribute to advances in the practice of project management (continuous improvement) • Maintain strong working relationships with study teams • Collaborate on issues identification and resolution with study teams (e.g., identify bottlenecks) • Ensure alignment with Integrated Project Plan • Inform management and stakeholders on status of and/or issues regarding program(s)/study timelines • Compile program or study-related information for use with or deliver to internal or external groups • Participate in (or lead) process improvement initiatives as assigned • Monitor progress against study plans and against established process metrics • Confirm acceptance of clinical study timelines with functional representatives ensuring alignment with key operational goals and timelines • Create scenario options in support of decision-making for operational or strategic direction

Qualifications

Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience

5 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company)

PMP Certification Knowledge

Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory

Project management tools and processes (e.g., MS Project, PowerPoint)

Strong computer literacy, including word processing, presentation, and spreadsheet applications

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

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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