Are you actively seeking for a new Senior Data Manager role in Berkeley Heights, New Jersey area? I have a One Year CONTRACT opportunity with an American biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders. If you meet the requirements, please send me your updated resume to Kelly.Hua@Yoh.Com. "You must be eligible to work in the US without sponsorship."
RESPONSIBILITIES will include, but are not limited to:
As a Sr Level person, will be assigned to more complex studies.
1. Oversee the management of clinical trial databases from study start up to study closure.
(A) Be able to review and understand protocol synopsis and attend if required any protocol review meetings and act as subject matter expert for proper data capture based on protocol requirements.
(B) Lead Case Report Form Design according to the protocol with all Study Team members using establed standards
(C) Author and or review CRF completion guidelines (
D) Develop or lead in the review of a Data Management Plan (DMP), when applicable, that outlines database design and testing, CRF flow, data queries, manual checks, coding, SAE reconciliation, third party vendor reconciliations,specification of data listings needed to facilitate data cleaning in accordance to a Data Review Plan, data lock and archiving, etc.
(E) Develop and test edit specifications which may include the development of test scripts used for UAT as well as perform/coordinate UAT testing
(F) When applicable ensure coding has been performed and reviewed by Medical Coder, Perform external data reconciliation, Provision of data managment related metrics, provision of specific data listings as required by the medical group and review when necessary
(G) Make data, including interim data, available to company personnel and to regulatory agencies when required
(H) Trouble-shoot database issues with DBA until resolution is obtained
(I) Perform database lock and freeze activities
(J) If required prepare and present data collection requirements at Investigator Meeting
(K) Be experienced in the managment and oversight of CROs and consultants:
(L) Participate in CRO selection if required
(M) Be able to Review SOWs for data management activities and costs in contracts
(N) Interact with CROs in the design and development of databases that are compatible with company needs, monitor progress of data management activities in CROs
(O) Participate in regular team meetings and provide input when appropriate
2. Other Activities may include:
- Writing function SOPs/Working Practices
- Interact with physicians, scientists, monitors, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
- Assist in database upgrades/migrations including performing User Acceptance Tests
- Train Data Managers on standards and processes
- Serve as the DM representative on clinical project teams that are developing NDAs
?REQUIRED KNOWLEDGE/SKILLS/ABILITIES (KSAs):
- Must be a Senior Level person familiar and experienced in all aspects of Data Management Responsibilities.
- Important: This contractor must be able to function as a SME, not just a task performer
- BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience as a LEAD data manager in a pharmaceutical/CRO setting
- Oncology experience
- Experienced in understanding Sponsor responsibilities of oversight of a CRO.
- Proficient knowledge of EDC preferably Medidata RAVE. Knowledge of JReview is a plus.
- Basic knowledge of budget forecasting
- Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
- Proficiency in regulatory guidelines, agencies, GCP
- Advanced knowledge of clinical trial process and data management process
Opportunity is Calling, Apply Now!
Recruiter: Kelly Hua
What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.
Medical, Dental & Vision Benefits
401K Retirement Saving Plan
Life & Disability Insurance
Direct Deposit & weekly ePayroll
Employee Discount Programs
Referral Bonus Programs
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