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Lead Clinical Data Manager

Employer
Labcorp
Location
Leeds, West Yorkshire (GB)
Salary
On application
Start date
18 Apr 2019
Closing date
18 May 2019

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Job Details

Job Description and summary

  • Lead Clinical Data manager required to work for Covance
  • Excellent opportunities to progress
  • Varied, fast paced environment
  • Office based in Leeds, Yorkshire, UK or work from home anywhere in Europe
  • Candidates must have Lead experience gained working as a Data Manager within a Biotech, CRO or Pharma company within Europe

Join our growing team and discover your extraordinary potential by working as a Covance Lead Data Manager within our Early Phase (Phases I & II) clinical data management department.  As a Lead Clinical Data Manager at Covance you will be responsible for the data management leadership for all aspects of the data management process to include responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. You will also assume responsibility for all data management activities leading to database lock according to Client quality expectations within project timelines and budgets.

Working within early phase data management we offer, in a word, variety

In the type of studies: PK, Bioequivalence, Metabolism, Dose Escalation etc. and Sponsors

  • In Early Phase we are not assigned for years to the same study, so you will be exposed to multiple studies for clients with different needs as well as working with talented internal colleagues

Job Primary Functions

  • Lead study Data Manager for studies
  • As the study data lead; be accountable for all DM deliverables 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 to ensure that all deliverables are met
  • Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies
  • Keep Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. 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
  • Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study
  • 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 in DM related clinical trial processes, department technical capabilities, and associated turnaround durations
  • Ensures service and quality meet agreed upon specifications per the DMP and scope of work
  • Have input in writing, reviewing and updating SOPs and associated documents as required
  • Performs QC on all aspects of work performed in DM to ensure that data quality and integrity is maintained.  Feedback constructively on relevant issues and initiate process review as appropriate
  • Perform quality control on all aspects of the study as appropriate
  • Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate. Utilise local laboratory systems and batch data load facilities where appropriate
  • Perform medical and medication coding
  • Oversee the performance of the Data Management Study team to ensure that client satisfaction is achieved through delivery of quality data, on-time and on-budget
  • Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe
  • Actively promote Biometrics services to sponsors whenever possible

Education

  • 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).

Job Requirements

  • Previous Lead experience gained working as a Data Manager within a Biotech, CRO or Pharma company within Europe
  • Knowledge of drug development process
  • Knowledge of effective clinical data management practices
  • Fluent in English, both written and verbal
  • 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 work in a team environment and collaborate with peers
  • 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

To apply, please click on the APPLY button. 

About Covance:

Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.

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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