*Healthcare Data Analyst*
location is Cambridge, MA
duration is 1-2 years
Phone, then face to face or potentially Skype
. The Data and Analytics Lead (DAL) role has a focus on Late Phase Clinical
Development, including post-marketing and Phase IV studies.
The Data and Analytics Lead manages the end to end clinical data flow (data
acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR)
of Clinical Data) and ensures timely project execution; recognized as an
operational specialist in data flow and study execution by all functions.
Partners with key study team members to facilitate implementation of a
robust and clear Data Strategy for assigned studies. Uses phase, TA and
operational knowledge to establish study level operational plans and
oversees CROs and other vendors to ensure timely execution. Develops study
level quality plans and ensures adherence and consistent execution across
the data flow. 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 and submission
deliverables in collaboration with cross functional team members and
? Oversees execution of data management deliverables. Interprets and
applies data strategy, verifies consistency and usage of data, results and
submissions 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
Liaises directly with internal customers (CDS functions, GCO, Regulatory
Affairs) and external customers (Full Service and Functional Service
Provider Data Leads and Project Management personnel, all other external
Partners (affiliates, etc.).
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.
Support study-level audit and inspection readiness activities as needed.
Serve as project manager on special projects and initiatives; Vendor
Management and Quality depending on type of project.
• Bachelor’s degree, preferably in a scientific discipline such as
Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social
• 8+ years relevant work experience with a focus on data management and/or
• Deep understanding of drug development and biopharmaceutical industry
• Strong project management skills, and ability to effectively lead and
collaborate with various business functions project management certified
• High attention to detail including proven ability to manage multiple,
• 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 and outsourcing with
full-service, global CROs and FSPs
• Demonstrated ability to influence without authority
• Excellent written and oral communication skills
*Sr IT Recruiter*
*IDC Technologies, Inc. 1851 McCarthy Boulevard, Suite 116,Milpitas, CA,
*Phone: 408-418-5779 ext 252 |Fax: 408-608-6088 | *
*Email: **ma...@idctechnologies.com* <kara...@idctechnologies.com>*| Web: *
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