Data Manager/Sr. Program Data Manager
Purdue Pharma - Stamford, CT

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Sr. Program Manager, Clinical Data Management (CDM) will lead data management activities for multiple drug projects and will work in the capacity of a data manager, accountable for the data management operations for specific clinical studies. Sr. Program Manager is responsible for contributing to the implementation of new processes and technologies. Sr. Program Manager will support CDM Supervisor by mentoring and managing internal staff and ensuring consistency in processes and practices across CDM disciplines and CRO vendors. Sr. Program Manager communicates to and manages the CRO data management counterparts regarding expectations, deliverables, and consistency in DM processes. PRINCIPAL ACCOUNTABILITIES: 1.Functions as the Data Management representative to Clinical Study Teams and/or the Clinical Project Team. Leads and manages the CDM activities across multiple studies and drug projects in the capacity of a data manager and through assigned internal staff and/or staff extenders. Demonstrates ability to support clinical teams by carrying forward good data management practices and reporting on data management issues/status. 2. While working in a collaborative spirit, must be comfortable with strong presentation and backing of overall CDM requirements and expectations at clinical study/project team meetings. 3. Reviews study design documents, protocols and amendments and provides comments to the author. Is a resource for questions on CDM sections of the protocol. 4. Participates in the selection and management of CROs/external data providers; attends and actively participates in vendor defense meetings. 5. Sr. Program Manager will work closely with all functional areas within Medical Research and Outsource Management to develop/improve processes for managing external vendors. 6. Contributes to the development of the data management section of the outsourcing contract, ensuring that language clearly represents data management activities and deliverable expectations according to clinical timelines. Reviews proposed budgets and considers comparisons to other studies and CROs. 7. Demonstrates highly effective leadership, communication and negotiation skills to manage the activities CROs/external data providers to receive quality deliverables as outlined in the scope of services and to ensure compliance with project timeline, expected database quality, and budget. 8. Plans and prepares CDM training materials and then delivers presentations to CRO staff in order to train them on CDM expectations and deliverables. Serves as liaison for first line CDM questions. 9. Tracks milestone achievements and approves CRO payments for CDM activities. 10. Interfaces with CDM Line Management to ensure rapid dissemination of all project/study related information. Contributes to build best practices and consistencies across all CDM activities performed internally or by CRO. 11. Contributes to the development and maintenance of department SOPs and WPDs, and may author new procedures. 12. Trains internal team members/functions on CDM process and standards as needed. 13. Develops and maintains internal CDM tracking reports. 14. Sr. Program Manager is assigned to special non-study projects and in some cases is the leader of the effort. Incumbent creates appropriate documentation, minutes, trackers and if applicable, provides metrics and outcomes to manager. Must demonstrate leadership abilities in chairing a team, working with an external vendor, or other internal functional areas. 15. Delivers presentations at internal/external meetings and to management as required. 16. Assists Line Manager in the professional growth of internal staff by developing training materials and establishing a learning environment with problem solving scenarios based on past experiences in CDM.

Educational Requirements BS/BA in a science related field and a minimum 6 years in data management. A Masters Degree in a science related field is beneficial.

Required Experience & Technical Requirements Technical Requirements The incumbent must have applied knowledge and understanding of the CDM functions and CDM requirements for Phase 1 through 4 Clinical Trials. Knowledge of GCPs and FDA/ICH guidelines is essential. Must have experience in clinical data standards and processes creation and implementation. Must have demonstrated experience in managing the data management activities of CROs and knowledge of external vendors (e.g., central labs, etc). Knowledge and experience with various CDM and database applications (e.g., Oracle Clinical, SAS, MS Office, EDC systems particularly with Medidata RAVE ) is required. Knowledge and experience in electronic data capture methods is required. More advanced oral and written communication skills are required for interactions with vendors and internal team members. Must have the ability to prepared and deliver presentations to internal colleagues and external vendors. Must demonstrate advanced organizational and planning skills which are critical in the day to day functions. Time management is essential to complete study related assignments as well as special projects. Effective leadership and interpersonal skills including managing CRO counterparts and influencing internal team members are required. Must have experience training and managing the activities of other internal staff.

Location
Stamford, CT

City
Stamford, CT

Contact Person
Karen Laurel Recruiter

Purdue Pharma - 19 months ago - save job
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Purdue Pharma helps bring patients relief from pain. The company specializes in developing, manufacturing, and marketing prescription and...