Sr Manager CDM - Oncology
- R+D/ Global Development Support
- Greater NY/NJ area
- Salary range: $150-175k base, bonus + additional benefits
A top biopharmaceutical company is looking to hire a Sr Manager CDM position. This position will report to the Director of Data Management.
The Senior Manager CDM position will have responsibilities that include:
- Support the project, development and execution of clinical reports and dashboards to enable the Global Development group to best meet the quality and processing needs, including CRO oversight, of the clinical trial data (from EDC and other external sources).
- Deliver to the data review strategy and push the selection of reports tools/platform.
- Enables the creation of study- specific data review reports specifications and aggregating data review reports to establish a statements library for use across studies.
- May assist related cross-functional data evaluation needs and tools for clinical study teams.
- Supply the development of the Data Management data review strategy and reports platform selection/implementation
- Convert clinical study teams needs into specifications and provide custom data review reports solutions
- Provide technical project management, report specifications development, deployment timelines for study-level and standard library-level reports
- Stay current on new product releases and recommend appropriate adoption to the users
- Contribute reports to support the Sponsor oversight to CROs and other data providers by developing targeted reports
- Build and maintain data review reports for all clinical data, to include integrated data, CRF data, eCOA and biomarker data.
- Liason with Medidata Rave to address special needs on reports
- Coordinate with Medical Monitoring Team and Data Analytics Team to meet business needs
- Support with the Data Governance Team to ensure data reports meet specification requirements
The ideal candidate will have the following skill set:
- If You have a BS in Computer Science, Engineering, Life Sciences or equivalent,. You have 5 or more years of experience in biotechnology, pharmaceutical or CRO settings and at least You have 3 or more years in reports development.
- Additionally, previous RAVE EDC experience a plus
- Strong experience in report development using main-stream report technologies like JReview, WebIntelligence, Buisness Objects 4, Spotfire, Oracle BI, or Crystal Reports.
- Experience with EDC and clinical data management systems: Medidata Rave is preferred.
- Experience in technical writing.
- Proficiency in SQL and scripting with advanced queries, stored procedures and views.
- SAS, R or Python programming is a plus.
- Experience in developing the tools/reports to support CRO oversight activities
- Understanding of statistical outputs (tables, listings and graphs) to ensure data review reports match asset needs
- Robust grasp of clinical trial data management concepts and challenges of data managers
- Detail oriented, ability to multi-task with strong prioritization, planning and organization skills
- Capability to analyze customer requirements and implement best fit solutions
- Great communication, work ethics and problem solving skills
- May supervise contractor report developers and/or DM FSP resources
