Senior Project Data Manager - Homebased

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Job Details

Job Overview:

Our Company:

Joining Covance Flexible Solutions (FSPx) will offer a rewarding career, a chance to work in an energetic & team oriented workplace, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Our unique opportunity will allow you to bring your specialized discipline to a core team outsourced to a world class leading global healthcare company. Dedicated to our Client 100% of the time, you will play a key role in the drug development cycle and see a product through to launch with the support of both a dedicated Covance line manager and our client project teams.

Your role:

The Senior Project Data Manager role is a great opportunity to work within our sponsor dedicated department and have this unique relationship with a sponsor.

You will also be able to manage the oversight of activities in data management on large scale projects.
This role is a great opportunity to lead projects and being sponsor dedicated.

• Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
• Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
• Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
• Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications.
• Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
• Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
• Advanced planning and risk management for projects (issue escalation, resource management).
• Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
• Assist with goal creation and performance review assessment for data review project staff.
• Maintain technical data management competencies via participation in internal and external training seminars.
• Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
• Identify areas for process and efficiency improvement and implement solutions on assigned projects.
• Support achievement of project revenue and operating margin for data management activities to agreed targets.
• Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.
• Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
• Review literature and research technologies/procedures for improving global data management practices.
• Perform other duties as assigned by management .

Education/Qualifications:

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

Experience:

• Broad knowledge of drug development processes.
• Understanding of global clinical development budgets and relationship to productivity targets.
• Knowledge of effective clinical data management practices.
• Knowledge of time and cost estimate development and pricing strategies.
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

Company info

Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
GB
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