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Senior Study Manager - Central Laboratory Services

Covance - Burlington, North Carolina

1/12/2018 4:53:19 PM
Scientific Bachelor s Degree

Job Overview

About this Opportunity

The Senior Study Manager is responsible for the successful delivery of the study management activities related to companion diagnostic studies. You will coordinate, plan, organize and oversee the completion of administrative and technical tasks during the companion diagnostic study life time in collaboration with the Principal Investigator, the regional laboratory testing site and the various internal departments involved in the deliverables of the study. This position is located in our Morrisville, NC office (it is not a remote opportunity).

You will be responsible for the effective communication between the regional Diagnostic Client, the Global Study Manager, and the regional laboratory operations testing site. This position is heavily project management focused.

Serving as a consultant/Technical Expert, you will provide recommendations/advice to all parties, day-to-day project management oversight, as well as study documentation maintanence in accordance with customer expectations and in compliance with regulatory requirements.

As the Senior Study Manager, you will be the "Go To" person for Commercial development services team members in charge of diagnostic services and for the Laboratory global directors.

Your knowledge and Experience in project management techniques related to diagnostic services will be invaluable in this role. You will be responsible for key client deliverables including budget, risk, and milestones management.

Your strong leadership skills and ability to keep a collaborative attitude and foster excellent communication within the team will contribute to the team's overall success. You must be able to combine a strong understanding of client protocol specifics and study feasibility, to ensure successful study management and provision of outstanding customer service.

Principal Day-to-Day duties

* Participate in and prepare for Client Audits related to Companion Diagnostic studies
* Prepare, organize, and host CRA visits as needed
* Prepare training support material for Laboratory staff to enhance and sustain study compliance
* Prepare, coordinate set up and monitors study timelines with the laboratory, the CRA and all CLS departments involved
* Serve as back up for Study Managers
* Prepare regulatory authority applications
* Prepare and send weekly and monthly monitoring reports to the client as agreed upon in the contract
* Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements
* Prepare, lead or facilitate client calls and internal operational/technical meetings including agenda preparation and taking minutes
* Coordinate and centralize the communication between stake holders
* Day-to-day global study related activities
* Ensure laboratory processes harmonization across CLS sites location
* Ensure Diagnostic protocols and program consistency across CLS sites location
* Ensure proper escalation of internal misalignment and inconsistencies and propose corrective and preventive actions
* Proactively assess and propose process improvement opportunities to the diagnostic client
* Manage client budget and provide regular updates
* Closely monitor key client metrics and deliverables from win to study closure
* Collaborate with commercial development team to assess and review new diagnostic opportunities
* Manage Regulatory duties
* Maintain all necessary study documentation, including but not limited to: study binders, material receipt forms, and material balance forms
* Participate in team meetings and take minutes
* Organize and archive study documentation and correspondence as requested by the client
* File and collate trial documentation and reports
* Track monthly Diagnostic services billable activities
* Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/Scientist
* Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/Scientist

About Covance

Covance, the drug development business of LabCorp, is the world's most comprehensive drug development services company. Because of our broad Experience , from early research to commercialization, our more than 20,000 employees from across the globe are in a unique position to supply insights that go above and beyond testing. Our team's impact on healthcare is remarkable. Through their everyday work they've supported 100% of the top 50 drugs on the market and all the oncology drugs approved in 2016. Even though we span multiple businesses, we operate as one, sharing our knowledge to improve our efficiency and deliver on the promise of a healthier world.

At Covance, you'll redefine what's possible and discover your extraordinary potential. You'll have the opportunity to personally advance scientific research and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients—and your career.


* Bachelor of Science degree required with preference for in Biology, Chemistry or other Life Science focus
* Master Science or PhD preferred
* Professional certification (ASCP, PMP or other) in area(s) expertise


Required Experience :

* 2 years of previous Experience in CCLS Project Manager/or and demonstrated levels of competency for this position OR 5 years of clinical laboratory Experience or customer service Experience , preferable in pharmaceutical industry.
* Experience in the field of Medical devices specifically with 21CFR820 compliance and/or multidisciplinary lab background is a plus.

Preferred Experience :

* Experience with design and development of molecular assays and or histopathology assays (IHC: Immunohistochemistry)
* Experience working in a regulated environment (GLP, cGMP, CLIA)
* Experience with molecular assay validation (per FDA design control & ISO regulation)
* Experience coordinating with laboratory management to schedule projects as per the study protocol and study schedule.

Position Type: Full-Time

Location: Burlington, NC - North Carolina

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