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Job Details

CLINICAL DATA MANAGER II / Leeds, United Kingdom

Company: Covance
Location: Leeds, United Kingdom
Reference: 2017-13134
Closing Date: 24 Nov 17
Type: Permanent
Salary (£): Competitive

Job Summary:

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


We are recruiting for our Early Phase Biometrics team in Leeds and are currently seeking to hire a Clinical Data Manager II to help support our global team across Phase I and Phase II clinical trials. This is a unique position, focusing on database build process, query resolution with clinics/sites, and globally interacting with study teams to successfully perform database lock to meet Client quality and integrity specifications, within project timelines and budgets. This is a permanent, full time position, based in our Leeds office.

About the Job
Within this position, you will Provide DM project team leadership and accountability, lead data focused project team meetings, meeting frequently with the study leads of Electronic Data Capture (EDC) Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned, coordinated interdepartmentally, and proactively identifying potential risks and mitigations, and effectively communicating data-driven discussions in order to achieve database lock dates with the highest possible data quality.

In addition, your duties will include:
- Serving as the Study DM for studies across the complexity spectrum
- As the study data lead; being accountable for all DM deliverables per the established timeline; providing instruction to their DM study team(s) and review of their study team's output to ensure the highest delivery quality, while adjusting resource allocations accordingly.
- Ensuring that all allocated projects are carried out in strict accordance with the relevant protocols, analysis plans, global harmonized SOPs, and the specified standards of GCP.
- Working with the PM(s) to build timelines to meet contracted milestones.
- Providing DM project team leadership and accountability; leading data focused internal project team meetings; meeting frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmentally; proactively identify potential risks/mitigations, effectively communicating data-driven discussions in order to achieve database lock dates; keeping the PM apprised of project progress.
- Maintaining awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consulting with PM and/or functional group management as necessary.
- Keeping PM, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts).
- Coordinating 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.
- Ensuring study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.
- Developing and maintaining client relationships and review client satisfaction surveys.
- Implementing appropriate action plans including driving process improvements and team training.
- Applying corrective interventions where necessary to maintain project budget compliance and profit expectations.
- Tracking scope changes and work with the Clinical Pharmacology PM to ensure that Sponsor approval is received and the scope change processed.
- Providing leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations.
- Ensuring service and quality meet agreed upon specifications per the DMP and scope of work
- Having input in writing, reviewing and updating SOPs and associated documents as required.
- Performing 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.
- Maintaining accurate records of all work undertaken.
- Performing quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration, discrepancy management; to ensure that internal and client quality standards are achieved.
- Performing 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.
- Performing medical coding of Adverse Events and Concomitant medication.
- Overseeing the performance of the DM Study team to ensure that client satisfaction is achieved through delivery of quality data, on-time and on-budget. Arrange internal or external meetings as appropriate.
- Attending and action client or internal audits as appropriate and resolving all issues within an appropriate timeframe, addressing client comments with the study team.
- Actively promoting Biometrics services to sponsors whenever possible.
- Performing other related duties as assigned by management

About You
To be successful in this position, you will need to be educated to Degree level (or equivalent) in a relevant area. Additionally, you will need to demonstrate:
- Knowledge of drug development process
- Knowledge of effective clinical data management practices
- Fluency in English, both written and verbal
- Considerable demonstrable Experience in DM with related Experience in Project Management related activities.
- Proven Experience in handling customer negotiations and Experience with managing Scope of Work and budgets.
- Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
- 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
- Good organizational ability, communication and interpersonal skills
- Team working skills and good collaborator skills
- Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events.
- Knowledge of medical terminology
- Knowledge of science or a scientific background is preferred.
- Good oral and written communication skills

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

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!

EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.

Keywords: Clinical Research, Clinical Data, Clinical Data Manager II, Phase I/II, Early Phase Biometrics, Manager, Clinical Pharmacology, GCP, BioPharmaceutical, Data Transfer Agreements, Clinical Data Management, Oncology, Cardiovascular, Neuroscience, Immunology, Infectious Diseases, Metabolism, Office Based, CRO, Pharmaceutical, Leeds, United Kingdom.

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Contact Information:

Address:  Covance Leeds

Website:  Visit Our Web Site

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