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Principal Clinical Data Manager

Employer
Labcorp
Location
Office based in Leeds or homebased anywhere in UK
Salary
Competitive
Start date
2 May 2019
Closing date
21 May 2019

Job Details

  • Principal Clinical Data Manager required to work for Covance
  • You must be an experienced Lead Clinical Data Manger with experience gained in a CRO or Pharma
  • Working on Phase I and IIa trials across numerous therapy areas
  • Office based in Leeds, Yorkshire or homebased anywhere in UK or South Africa

Covance is seeking a Principal Clinical Data Manager to work in their early phase department (Phase I and IIa) across numerous therapy areas.  We are looking for very experienced Lead Clinical Data Managers who have programme level responsibility.  Office based Leeds, Yorkshire or home based anywhere in UK or South Africa.  This an incredibly exciting time to be joining Covance as we continue to grow and expand.

Job Primary Functions

  • Lead Study Data Manager for studies which are highly complex
  • As the study data lead/Client programme lead; be accountable for all DM deliverables as assigned per the established timeline
  • Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings
  • Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary
  • Keep Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. budget status, work scope changes, timeline impacts)
  • Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion
  • Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training
  • Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed.
  • Provides leadership, mentorship, and coaching
  • Provide support to Data Management supervisors and managers on the performance evaluation of other team members; provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards
  • Have input in writing, reviewing and updating SOPs and associated documents as required
  • Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilize local laboratory systems and batch data load facilities where appropriate
  • Represent Data Management and where necessary overall Biometrics in new business opportunities
  • Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
  • Works with management team to develop and implement directional strategy by providing technical input into discussions, and rolling out training/mentorship to DM staff as required
  • Actively represent Data Management at internal strategy calls, pricing review calls, and other meetings as required for scope/pricing decisions

 Job 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)
  • Knowledge of effective clinical data management practices
  • Fluent in English, both written and verbal
  • Extensive experience gained in early or late stage DM experience with four years of direct sponsor management and some technical mentoring experience. Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets
  • Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies
  • Time management skill and ability to adhere to project productivity metrics and timelines
  • Ability to mentor junior members of the department, providing SME guidance on Data Management practices
  • Experience of representing Data Management in bid defence meetings, providing innovative solutions to meet client needs
  • Good organizational ability, communication and interpersonal skills
  • Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events

PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE

NO AGENCIES PLEASE

MORE INFORMATION AVAILABLE ON REQUEST

For a confidential discussion about this opportunity, please phone Peter Lewis +44 (0) 1628 543 457.  To apply, please send your CV to peter.lewis@covance.com

 

About Covance:

As the drug development business of LabCorp and the world’s most comprehensive drug development service company, we have helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today.  Because of our broad experience and specialized expertise, we’re in a unique position to supply insights that go above and beyond testing.  Together with our clients, we create solutions that transform potential into reality.  For more information on Covance please visit: www.covance.com

Keywords:

Medidata, RAVE, EDC, Electronic Data Capture, Lead Clinical Data Manager, Principal Clinical Data Manager, Programme Clinical Data Manager, Clinical Data Management, pharma, pharmaceutical, home based, field based, home-based, office based, UK, United Kingdom, England, Scotland, Wales, flexible location, Covance, Chiltern, CRO, Contract Research Organisation, Early Phase, Phase I, Phase II.

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
United Kingdom

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