ClinicalData and Analytics Lead
At a glance
Senior Data Analysis & BI role at Integrated Resources INC. Cambridge · no salary stated · we estimate $113,700–$164,639 across the United States.
Integrated Resources INC has not published a salary for this role. The figure below is our estimate, not theirs.
dataroles summary, based on the employer's posting.
What you'll do
- Guide clinical study data from the case report form through the clinical study report, keeping work on schedule and aligned across teams
- Set study-level operating and quality plans, then track whether data work follows them consistently
- Coordinate outsourced data management and vendor delivery, addressing performance problems and escalating issues when needed
- Track study timelines, deliverables, risks and progress, and build action plans to protect data quality
- Serve as the main link between data management, clinical study teams and internal or external partners
What you bring
- At least five years of relevant work centered on data management
- A strong grasp of drug development and the biopharmaceutical industry
- Experience overseeing vendors doing outsourced clinical trial work
- Deep knowledge of clinical data management with global CROs and FSPs
Who this fits
This senior role suits someone who can lead clinical data operations, manage competing priorities and influence partners without direct authority. The position is based onsite in Cambridge, Massachusetts, for one year, with a possible extension.
From the employer
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
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
• 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
Warm Regards
Nancy
732-549-5307
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