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Data Manager/Senior Data Manager
The Data Manager/Senior Data Manager (SDM) ensures accurate and consistent handling of clinical data, as well as ensuring data management tasks are conducted according to applicable SOPs and GCP guidelines. The SDM will be responsible for the oversight of CRO clinical data management activities for 2 – 3 clinical trials at any one time, possibly across therapeutic areas. He / she will work in close collaboration with the clinical operations team and will report to the Director, Clinical Data Management.
Specific responsibilities include, but are not limited to:
- Assumes the lead role in oversight of CROs for all data management for assigned studies;
- Assists in the evaluation of central service providers (e.g., CROs, central laboratories, central ECG readers, central PSG readers, EDC vendors);
- Assists in the design case report forms and subject diaries to ensure that the information required for statistical analysis is collected;
- Develop and maintain standard edit checks; review CRO edit documentation for inclusion of Neurogen standards;
- Conducts sponsor User Acceptance Testing (UAT) of EDC systems to assure screen design matches protocol; Test system edits confirming correct operation;
- Ensures timely and accurate development of clinical databases, data entry screens, and edit check programs;
- Reviews and approves CRO data management deliverables from CRF development through database lock.
- Evaluate CRO database deliverables for adherence to defined standards; Review clinical data SAS datasets delivered by CROs; Confirm or reject based on adherence to clinical standards;
- Coordinates data quality control process, or ensures these activities are appropriately performed by CRO;
- Code clinical data using MedDRA for Adverse Events and Medical History and WHO DD for Medications;
Job Requirements:
- Bachelor’s degree minimum, scientific discipline desired; Masters level a plus;
- a minimum of 5 years related Data Management experience, at least 2 of those years as a lead data manager for a clinical development program;
- The candidate must have an excellent knowledge and understanding of data management requirements for pre-marketing clinical trials.
- Excellent oral and written communication skills are required. Organizational and planning skills, as well as excellent computer skills are critical in the day to day functions.
- Good interpersonal skills including team dynamics, communication with CROs and other vendors, negotiating and conflict resolution are required.
- Attention to detail and the ability to identify issues and propose solutions are essential.
- Good analytical and problem solving skills are critical
- Must be knowledgeable in GCPs, and the the drug development process;
- Must have experience with external vendors such as CROs, central service providers (e.g., central laboratories or ECG facilities) and independent statisticians;
- Prior experience with electronic data capture (EDC) is required;
- Familiarity with MedDRA and coding of clinical data is a plus. Must be familiar with medical terminology;
- Experience programming in SAS or similar software to aid in the ongoing review of clinical data is highly desirable;
- Experience with CDISC SDTM is a plus;
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