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Job Details

Senior Clinical Data Management Coordinator

Company: Covance
Location: Maidenhead, Berkshire
Reference: 61509BR
Closing Date: 27 Oct 16
Type: Permanent
Salary (£): Competitive

Job Summary:

We are recruiting for our Clinical Data Management team in Maidenhead and are currently seeking to hire a Senior Clinical Data Management Coordinator to help support the team with the delivery of Data Management solutions on clinical projects on time, and to budget. This is a full time, permanent position based in our Maidenhead office.


COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. 

We are recruiting for our Clinical Data Management team in Maidenhead and are currently seeking to hire a Senior Clinical Data Management Coordinator to help support the team with the delivery of Data Management solutions on clinical projects on time, and to budget. This is a full time, permanent position based in our Maidenhead office. 

About the Job:
Within this position, your duties will include: 

  • Serve as the technical data management leader on small to moderate project with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets. 
  • Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instruction, etc) to identify erroneous, missing, incomplete, or implausible data. 
  • Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data. 
  • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database. 
  • Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application. 
  • Perform reconciliation of the clinical and safety databases. 
  • Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, speciality laboratory, etc.). 
  • Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation 
  • Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved. 
  • Serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc. 
  • Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data. 
  • Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications. 
  • Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions. 
  • Assist in the development and testing of data management system 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 speciality 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. 
  • Serve as client contact for project meetings and CDM status updates. 
  • Potentially support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities. 
  • Support the training of project staff on project-specific, global, standardized data management processes. 
  • Maintain technical data management competencies via participation in internal and external training seminars. 
  • Review literature and research technologies/procedures for improving global data management practices. 

About You:
To be successful in this position, you will need to hold a 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). 

Additionally, you will need to demonstrate: 

  • Broad knowledge of drug development process. 
  • Understanding of global clinical development budgets and relationship to productivity targets. 
  • Knowledge of effective clinical data management practices. 
  • Cursory 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. 
  • Considerable relevant work experience with increasing responsibility in data management with knowledge of two (2) or more therapeutic areas. 
  • Demonstrated time management skill and ability to adhere to project productivity metrics and timelines. 
  • Excellent oral and written communication skills and demonstrated presentation skills. 
  • Knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
  • Working Knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies. 
  • Potential ability to lead by example data management staff. 
  • Demonstrated ability to work in a team environment and collaborate with peers. 
  • Demonstrated interpersonal skills. 

We Offer:
The opportunity to work within an experienced and highly skilled team. 
Covance offers a comprehensive benefits package including health cover, life assurance and a contributory pension scheme 

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. 
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. 

There is no better time to join us!


Keywords: Clinical research, clinical data management, CDM, data management plan, ADaM, CRO, Clinical Data Management, Clinical Data Manager, Data Manager, CDM, eCRF, eDiary, data coding, Maidenhead, Berkshire.

Apply for this job: Senior Clinical Data Management Coordinator

Contact Information:

Address:  Covance- Brussels

Website:  Visit Our Web Site

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