One of our leading clients, a leading health services research firm headquartered in Wilmington, DE is seeking an experienced Leading Clinical Data Management Lead to join our team in our Wilmington, DE providing oversight of both the client's Electronic Data Capture (iMedNet) system and Database lock per protocol timelines, as well as supporting the design of the electronic Case Report Forms (eCRFs) for late phase research studies.
This role is a renewable contract opportunity with a company that has an excellent track record of extending contracts in order to retain top talent.
Please find the qualifications and requirements below. If you feel that this position is one that you are excited about and qualified for, please send over your most recent CV. We are always interested in talking to candidates for current AND future opportunities! Please respond directly at with your resume attached
This opportunity is a temp-to-hire based on W2, 1099 or Corp-to-Corp. We also have other many other openings in our Pharmaceutical/Biotechnology/Medical Device group. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact Rose Chu, VP in Pharmaceutical & Biotech Services Group at # for questions.
The primary role of the Clinical Data Management Lead is to:
Provide oversight of both the client's Electronic Data Capture (EDC) system and Database lock per protocol timelines
Supporting the design of the electronic Case Report Forms (eCRFs) for late phase research studies.
Supporting the data collection efforts in study types such as Patient/Provider Surveys, Focus Groups and Medical Record Abstraction studies.
Represents the data management functions in client-facing and internal meetings.
Provides data management input to proposals and protocols.
Contributes to budget content and lead initial budget build of the data management scope.
Develops and manages timelines for key data management deliverables in coordination with the various area functional leads.
Monitors vendor performance to ensure timelines and data quality standards are met.
Reviews and approves key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, and electronic data transfer agreements.
Reviews final versions of survey materials and medical record abstraction data collection forms for completeness and quality.
Performs UAT on all data collection mechanisms.
Oversees all data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing data to ensure completeness, accuracy and consistency of all databases.
Develops or updates clinical data management Processes, Guidelines and Standard Operating Procedures (SOPs).
Provides mentoring and training to Data Management staff.
Acts as escalation point for issues arising from site startup data collection through database lock.
Assigns Data Associates to studies and sites based on experience, geographic location, and time coverage.
Regularly review metrics reports to ensure quality and timeliness with the scope of work, and identify out of scope activities.
Monitors overall study progress daily/weekly and proactively develops or adjusts plans as needed to achieve targets.
Sound understanding of pertinent regulations such as ICH-GCP guidelines and 21CFR11.
Requires BS degree in a life sciences field or relevant education and/or equivalent training in health services research, or a related field.
7+ years of CDM Experience including Data Management Leadership and Late Phase Research experience.
iMedNet EDC experience preferred.
A solid understanding of late phase data management and how functions such as health economics, outcomes research, and epidemiology play a role in these studies.
Previous experience with claims data and clams databases is a plus
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We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc-Lead CDM) in the subject line of your correspondence to ensure review.
Please forward your credentials in Word format through Indeed or call Rose Chu at for questions. Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.
Global Employment Solutions/Fahrenheit IT
P C F )
One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004
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Analyst, Biotechnology, CASE, Database, Data Collection, Development, Manager, Management, Materials, Medical Device, Metrics, Protocol, Protocols, Recruiter, Research