1. Choose your Affinity Group

* Equal Opportunity / Affirmative Action

We serve Equal Opportunity Employers and are an Equal Opportunity Employer. The Professional Diversity Network has separate professional networking sites for different affinities, and in selecting the groups you identify with, you will be joined with those networks.

Note: Providing this information is strictly voluntary - you will not be penalized or subjected to adverse treatment. If you choose not to provide this information, simply select "Choose not to identify."

2. Choose Method
X
Sign in with LinkedIn
Sign in with Facebook
OR

Tell us about yourself

Senior Data Manager - NJ
at Apex Systems, Inc.
Berkeley Heights, NJ

Senior Data Manager - NJ
at Apex Systems, Inc.
Berkeley Heights, NJ

Save or bookmark jobs as you go and access them anytime later with your account.

Contacts

Description

Responsibilities will include, but are not limited to:

1. Manage outside CROs and consultants:

  • Participate in CRO selection
  • Review SOWs/data management activities and costs in contracts
  • Interact with CROs in the design and development of CRF's, databases that are compatible with Standards, CDISC and all other company needs
  • Perform QC of CRO activities to include UAT, Query management, Data review, DM documentation such as DMP, DVS, edit checks, coding, lock process
  • Monitor progress of data management activities by CROs
  • Participate in regular team meetings and provide input when appropriate
  • Ensure inspection readiness by ensuring quality eTMF.

2. Other Activities:

  • Proficient in writing function SOPs/Working Practices
  • Interact with CRAs, 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 QC of CRO User Acceptance Tests

Skills/Knowledge Required:

  • Must have relevant and extended experience. Must be able to work with minimal supervision. Must be able to communicate well. Must have experience in managing data management deliverables end to end. Project driven, not task driven.
  • 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
  • Knowledge of Medical Affairs
  • Experience in Hematology and or Oncology
  • Proficient knowledge of EDC databases, preferably Medidata RAVE.
  • 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

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.


VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.

Similar Jobs

See All »

Other Jobs at Apex Systems, Inc.

See All »