At Covance, your imagination, your dedication, and your drive to find solutions to challenging projects begin on your very first day. Covance is one of the world’s largest and most respected contract research organizations. Our clients are a Who’s Who of the pharmaceutical and biotechnology industry. If you’re looking for a diverse and stimulating work environment, you'll find it at Covance.

Currently we have an exciting opportunity for a Senior Manager, Clinical Data Management.

As a Senior Manager, Clinical Data Management you will:
Assume responsibilities for delivering data management services to clients and project teams. Responsibilities will be to provide [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data. Serve as the project and client liaison including provision of project specific data management status, cycle time, and productivity metrics. Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications. Supervise, mentor and evaluate performance of staff to ensure career development, interpersonal skills, and achievement of competency standards.

Position Location: Princeton, NJ

Qualifications:

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).  Additional relevant work experience will be considered in lieu of formal qualifications.

Minimum seven (7) years relevant work experience in data management with four (4) years technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.

Demonstrated skill for technical and supervisory leadership of 8-15 staff within one or more locations in a region.

In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.

In depth knowledge of tracking of staff productivity and quality metrics.

Demonstrated skill for mentoring and developing staff on technical and core competencies.

Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.

Operational experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc.

Demonstrated ability to lead by example teams on strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.

Broad knowledge of drug development process.

Understanding of global clinical development budgets and relationship to productivity targets.

Thorough knowledge of effective clinical data management practices.

Thorough 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, especially as related to data handling and processing.

Covance believes that their best-in-class employees deserve first-class benefits.  The Company offers an outstanding benefits package including medical & dental insurance, tuition reimbursement, a 401(k) plan with a generous company match, short- and long-term disability, and life insurance, all of which are effective on the first day of employment!  

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.

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.

 

At Covance, your imagination, your dedication, and your drive to find solutions to challenging projects begin on your very first day. Covance is one of the world’s largest and most respected contract research organizations. Our clients are a Who’s Who of the pharmaceutical and biotechnology industry. If you’re looking for a diverse and stimulating work environment, you'll find it at Covance.

Currently we have an exciting opportunity for a Senior Manager, Clinical Data Management.

As a Senior Manager, Clinical Data Management you will:
Assume responsibilities for delivering data management services to clients and project teams. Responsibilities will be to provide [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data. Serve as the project and client liaison including provision of project specific data management status, cycle time, and productivity metrics. Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications. Supervise, mentor and evaluate performance of staff to ensure career development, interpersonal skills, and achievement of competency standards.

Position Location: Princeton, NJ

Qualifications:

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).  Additional relevant work experience will be considered in lieu of formal qualifications.

Minimum seven (7) years relevant work experience in data management with four (4) years technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.

Demonstrated skill for technical and supervisory leadership of 8-15 staff within one or more locations in a region.

In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.

In depth knowledge of tracking of staff productivity and quality metrics.

Demonstrated skill for mentoring and developing staff on technical and core competencies.

Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.

Operational experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc.

Demonstrated ability to lead by example teams on strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.

Broad knowledge of drug development process.

Understanding of global clinical development budgets and relationship to productivity targets.

Thorough knowledge of effective clinical data management practices.

Thorough 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, especially as related to data handling and processing.

Covance believes that their best-in-class employees deserve first-class benefits.  The Company offers an outstanding benefits package including medical & dental insurance, tuition reimbursement, a 401(k) plan with a generous company match, short- and long-term disability, and life insurance, all of which are effective on the first day of employment!  

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.

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.