Clinical Data Manager

Company Name:
Global Employment Solutions, Inc.
One of our top Pharmaceutical clients is in search of an exceptional Senior Clinical Data Associate in DE/DC/MD/VA areas. The Sr. Clinical Data Associate is responsible for:

1. Managing the Data Mgmt processes with various CRO partners, presenting at CRT meetings on Data Mgmt issues.
2. Protocol and CRF review, database setup through database lock activities.
3. Providing oversight management of several CROs based upon existing studies outsourced to CRO partners.
4. Proven leadership in handling multiple projects.
If you are a qualified Senior Clinical Data Associate/Clinical Data
, looking for a contract/project, contract-to-hire, or full-time basis, we'd love to talk to you!

Pharmaceutical industry experience required

o Responsible for reviewing protocols for clinical trials.
o Complies with enforced standards from FDA and coordinates related parties.
o Keeps milestones in the timeline of the project, including assuring databases are locked on time.
o Liaises with Programming to ensure development of database, data entry screens, and edit check programs.
o Manages user acceptance testing of databases and software.
o Assists in data acquisition from external sources, e.g. central laboratories and CROs.
o Provides input for Case Report Form Development.
o Performs Database Setup activities for both paper and Electronic Data Capture trials.
o Performs Data Cleaning activities for both paper and Electronic Data Capture trials. Proactively identifies and implements opportunities for process improvement.
o Performs Database Release and Lock activities for both paper and Electronic Data Capture trials.
o Manages vendors according to the protocol, troubleshoots vendor accuracy and competence.
o Functions as Data Management representative on clinical project teams.
o Provides progress reports and data reports to the team. Provides data management expertise to the team to illustrate potential issues and offers proactive solutions.
Please respond directly to Global Employment Solutions, Inc. at with your resume attached - WORD document.
Requirement for Sr. CDA:

o Bachelor's degree preferred in a scientific field; with a minimum of 7 years of pure Data Management experience in pharmaceutical industry (Will accept resumes of non-degreed candidates with extensive background in Data Management).
o Working knowledge of the pharmaceutical industry and an understanding of protocols and scientific terminology.
o Strong
skills with demonstrated experience in working with EDC.

Please respond directly to Global Employment Solutions, Inc. at with your resume attached - If you choose to respond on line through CareerBuilder.com, please do attach your resume in WORD document.
If you have 7+ years CDM experience within pharmaceutical industry/strong in EDC and CRO management, please send your resume to . Our clinical recruiter/account manager will contact you with more details.
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
ID (rc-CDM/CDA) in the subject line of your correspondence to ensure review. Please forward your credentials in Word format, in confidence, to: .
Rose Chu
Vice President, Pharmaceutical & CRO
Global Employment Solutions, Inc.
One Presidential Blvd. North, Suite 310
Bala Cynwyd, PA 19004
610.822.1256 phone
610.822.1210 facsimile

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