Covance

  • Principal Clinical Data Manager

    Job Location(s) UK-Leeds | UK-Maidenhead | UK-London | UK-Alnwick | UK-Crawley | UK-Harrogate | UK-Horsham | UK-York
    Job Number
    2018-24805
    Job Category
    Clinical Data Management
    Position Type
    Full-Time
  • Job Overview

    • 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

    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.  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 including but not limited to - combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines
    • 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
    • Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress
    • 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

    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)
    • Knowledge of effective clinical data management practices
    • Fluent in English, both written and verbal

    Experience

    • Ten years of combined early or late stage DM experience with four years of direct sponsor management and at least 2 years 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. 

     

    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.

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