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Clinical Project Manager

Covance - Kansas City, Missouri
Wednesday, August 28, 2013
Biotechnology Pharmaceutical

Covance is seeking a Project Integration Manager. This position can work from Madison or one of our other offices. We may consider remote work for a strong individual. Relocation benefits are provided as well.

- Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, analysis plans, SOPs, and the specified standards of GCPs
- Clarify specific CDARO requirements from clients
- Communicate on a regular basis with assigned clients regarding questions, concerns, and project status
- Identifies operational and logistical challenges and solutions
- Organize, chair, and record minutes for all relevant CDARO project meetings
- Facilitate meetings with Sponsors and develop working relationships with client companies
- Ensure the relevant personnel are kept informed of problems that may affect the project performance
- Coordinate receipt and inventory of study related information. Ensure all appropriate documentation and procedures are performed upon project completion
- Liaise with Quality Assurance regarding regulatory compliance of study reporting and Sponsor audits
- Elicit and coordinate interdepartmental communication

- Document and circulate client interactions
- Communicate with the Data Management, Programming, Statistics, Pharmacokinetics, Medical Writing, and QA departments regarding study progress and reporting requirements
- Update the CDARO timelines for allocated projects in a timely manner. Renegotiate timelines as appropriate
- Responsible for timely production of deliverables
- Liaise with Covance offices or external data vendors as appropriate with regard to the schedules of data availability
- Liaise with the Sponsor over documentation required for the report preparation process
- Keep CDARO management team and/or client services informed of pertinent project or client related information (i.e., work scope changes)
- Develop an in-depth knowledge of all Covance CDARO capabilities
- Ensure client satisfaction surveys are provided to clients. Distribute comments to the CDARO study team and managers as appropriate
- Actively promote CDARO services to clients whenever possible
- Write and update SOPs as required
- Performs other related duties as assigned
Education/Qualifications - BS or BSc in Science, Medical, or related field
- Knowledge/experience with drug development
- Knowledge/experience clinical research preferred
Experience - 3-4 years of related experience
- Additional experience may be substituted for education requirements
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.

Kansas City, MO

Kansas City, Missouri