Clinical Data Manager I

Covance Inc Located in: Chicago, Madison,  Illinois
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JOB DESCRIPTION

Clinical Data Manager I

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 Clinical Data Management team in Leeds and are currently seeking to hire a Clinical Data Manager to serve as a member of the project team with primary responsibility for leading all aspects of the data management process to include but not limited to the development of the project documentation, system set-up, data entry, and data validation procedures and processes assigned to more junior staff. This is a full time position based in the Madison, WI office.

About the Job
Within this role you will be expected to:
* Lead study Data Manager for studies considered to be lower complexity either in terms of study design or client management.

* As the study data lead; be 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.

* Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.

* 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 site 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 Clinical Pharmacology Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts).

* Anticipates and identifies operational and logistical challenges; including mitigation plans and risk management plans and reviews them with the Project Manager, Biometrics management, and the sponsor. Executes follow-through of mitigation plans to completion in a timely manner.

* 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.

* Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.

* Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Project Manager to ensure that Sponsor approval is received and the scope change processed.

* Demonstrates knowledge of DM utilized tools, systems, and processes.

* Ensures service and quality meet agreed upon specifications per the DMP and scope of work.

* Plan Data Management resources for assigned studies with support from line manager

* Maintain accurate records of all work undertaken.

* Perform quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved.

* 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.

* 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.

* Support and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.

* Actively promote Biometrics services to sponsors whenever possible.

About You
To be successful in this position, you will need to be educated to Degree level (or equivalent) ideally in a Life Science, Pharmacy or related area. Additionally, you will need to demonstrate:
• Working knowledge of drug development process
• Working knowledge of effective clinical data management practices
• Fluent in English, both written and verbal


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!

CRITICAL REQUIREMENTS

COMPANY INFORMATION

Covance Inc. is proud to be the only drug development company with a full range of research and development services—from lead optimization, to commercialization and life cycle management. Covance, headquartered in Princeton, NJ, is the drug development business of LabCorp with global operations in more than 30 countries.

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
  Clinical Research / Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: