ClinicalData and Analytics Lead

Job Title: ClinicalData and Analytics Lead

Location: Cambridge MA

Duration: 1 year (+possible extension)

Position Responsibilities

• The Biometrics department is strategically focused on optimizing the data flow of clinical data from CRF to submission, including but not limited to Data Management and Statistical Programming (Clinical Data Sciences or CDS), and Biostatistics. The four areas of focus for CDS include Data Planning, Data Operations, Data and Analysis Infrastructure, and Quality and Process Management.

• The Data and Analytics Lead (DAL) role is part of the Data Operations group with a focus on Clinical Data Management.

• The Data and Analytics Lead (DAL) manages the end to end clinical data flow (CRF) to Clinical Study Report (CSR) and ensures timely project execution and is recognized as an operational specialist in

• Data flow and study execution by all functions across Global Development. The DAL utilizes phase, therapeutic area, data standards, and operational knowledge to establish study level operational plans and oversees CROs and other vendors to ensure timely execution. The DAL develops study level quality plans and ensures adherence and consistent execution across the data flow. Finally, the DAL collaborates with Program DALs to ensure alignment of study operational plans with program goals and for execution and quality.

• Develops timeline and project manages all end to end data deliverables in collaboration with cross functional team members and vendors.

• Oversees execution of data management, interprets and applies data strategy, verifies consistency and usage of data, results and submissions standards.

• Coordinates and oversees outsourced Data Management 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.

• Primary contact between Data Management and clinical study management teams (SMT and/or Clinical Development Team representatives).

• Liaises directly with internal customers (Medical functions, Statistical Programming, Clinical Operations, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service

• Provider Data Leads and Project Management personnel).

• Serves as Subject Matter Expert 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.

• Supports study-level audit and inspection readiness activities as needed.

• Serves as project manager on special projects and initiatives; partners with Statistical Programming, Vendor Management, and Quality depending on type of project.

Education:

Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.

Qualifications

Qualifications

• 5+ years relevant work experience with a focus on data management • Deep understanding of drug development and biopharmaceutical industry required • Strong project management skills, and ability to effectively lead and collaborate with various business functions • High attention to detail including proven ability to manage multiple competing priorities • Experience overseeing outsourced clinical trials work performed by vendors • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at vendor • Deep knowledge of clinical data management with full-service global CROs and FSPs • Demonstrated ability to influence without authority • Excellent written and oral communication skill

Additional Information

Warm Regards

Nancy

732-549-5307