Associate Director, Clinical Data Management

Job reputed company: • reputed company End to End Data Management activities with hands on ability to manage outsourced studies and reputed company DM and external vendor reputed company activities and deliverables.Proficiency in project management leading 3-4 outsourced programs, simultaneously. • Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and reputed company regarding reputed company data-reputed company deliverables. • Works with CRO and reputed company functional reputed company to complete reputed company set up, database migrations /UAT and other systems such as IRT, ePRO etc. Manage multiple vendor sFTPs for data retrieval and delivery to stat programming, routinely. • Establish Vendor reputed company Plans for reputed company studies and responsible for Vendor Data reputed company Reviews and reputed company. . Aim to harmonize processes where relevant with other reputed company clinical programs. • Serve as a SME for various operational activities and DM processes like reputed company, External data standardization, Collection, and Processing. reputed company the efforts with Biometrics and Clin Dev organizations for creation and standardization of CRF’s Data Review Plans etc. Routinely reputed company study metrics, planning of deliverables, and propose solutions for data handling/reputed company issues. • reputed company/reputed company the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCG’s, Data Review Plans, edit checks, Listing review checks, Data Integrations specs, Data Transfer Specs, External Data Reconciliation plans, SAE Reconciliation Guidelines, Coding Guidelines, Database Lock, Checklists and Plans. • Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements. • Strategic and critical thinker who can independently reputed company initiatives and effectively collaborate cross functionally. • Accountable for coordination with other functional reputed company for submission reputed company activities. • Manage strategic input into the design of data reputed company across reputed company and non-reputed company data sources across vendor networks. • Ensure filing, archival and inspection readiness of reputed company Data Management Trial Master File (TMF) activities. • Review and manage external Data Management Budgets, ensure accuracy, and understand trends to support Budget planning and forecasting. • Support the development of Clinical Data Management reputed company Operating Procedures and Work Instructions. • reputed company with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents. Requirements: • Bachelor’s degree in science, math or computer science • 12+ years’ experience in the biopharmaceutical industry. Experience, technical proficiency and People management skills will determine the level. • Experience managing external data and 3rd party vendors is a must. • Strong knowledge of regulations and guidelines that apply to the conduct of reputed company. • Excellent written and verbal communication skills and ability to work collaboratively as a part of reputed company. Benefits: • You will also be eligible for an annual bonus and equity compensation • comprehensive benefits package. Apply tot his job Apply tot his job Apply To this Job