Data Management Lead
Location: Waltham, Massachusetts
Data Management Lead
The Data Management Team provides program and project oversight of outsourced clinical trials and is part of the Global Biometrics department, which consists of Data Management, Biostatistics and Statistical Programming. The Program Data Management Lead ensures consistent application of Clinical Data Management operational decisions, data standards, and process within a program or group of studies.; recognized as an operational specialist in clinical data flow and study execution by all functions across Development Sciences. Partners with key study team members to facilitate implementation of a robust and clear data strategy plan for studies within assigned program. Uses program, phase, TA and operational knowledge to establish study level operational plans and works with DM leads at CROs and other vendors to ensure timely execution. Develops program/study level quality plans to ensure alignment of study operational plans with program goals.
Technical QA Analyst
Created and reviews user acceptance test scripts for quality and completeness and performs Technical review and facilitates UAT process to ensure high quality results, feedback, and compliance with industry and Bioverativ best practices. Conducts peer review and QC of clinical programming deliverables from internal and vendor employees, providing feedback to internal and vendor employees as needed.
Performs additional clinical programming tasks including but not limited to data archiving, data loading and report creation. Works with requestor to define requirements and performs or QCs programming.
• Conducts Centralized EDC UAT
• Technical review and QC of eCRF build
• Technical review and QC of Edit Check build
Develops program timeline and monitors data deliverables for all studies within assigned program in collaboration with cross functional team members and vendors.
Develops/Interprets and applies data strategy, verifies consistency and usage of data standards
Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data.
Develops risk mitigation or action plans and oversees execution when appropriate.
Serves as a contact representing DM within Biometrics and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (Biometrics functions, GCO, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
Serves as Subject Matter Expert alongside Biometrics counterparts for data, reporting, and analysis process definition, improvement, and innovation as needed
Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed
Support study-level audit and inspection readiness activities as needed
Serve as project manager on special projects and initiatives; partners with Statistical Programming, VM and Quality depending on type of project
Deep understanding of drug development and biopharmaceutical industry required
Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
Knowledge of GCP and other regulations
High attention to detail including proven ability to manage multiple, competing priorities
Experience overseeing outsourced clinical trials work
Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
Deep knowledge of clinical data management outsourcing with full-service, global CROs and FSPs
Expertise in clinical program indications, end points, dataflow, data integrity, standards, and data quality
Demonstrated ability to influence without authority
Excellent written and oral communication skills
Technical/Software Skills: Expertise with Medidata RAVE/Inform and/or other clinical data management software; Expertise in SQL, PL/SQL; detailed understanding of CDMS database structures. General software skills: MS Access, MS Word, MS Excel, MS Project, Visio, familiarity with medical coding dictionaries
Experience writing UAT scripts and executing UAT scripts for testing of electronic data capture systems including eCOA (electronic Clinical Outcomes Assessments) and EDC databases, to ensure that all clinical trial databases and electronic collection tools are consistent with the needs of the study protocol and department standards and procedures.
Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
10+ years relevant work experience with a focus on data management, Clinical Database Programming, Deep understanding of drug development and biopharmaceutical industry required