Katalyst CRO · 1 month ago
3rd party data acquisition Study Analyst
Boston, MA
Contract
Onsite
Mid, Senior LevelKatalyst Healthcares & Life Sciences is seeking a 3rd party data acquisition Study Analyst to serve as the subject matter expert for planning and acquiring external clinical data. The role involves managing study startup, ensuring compliance with standards, and developing relationships with key stakeholders in the clinical data process.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout activities
Create external data transfer agreements, ensuring alignment with company standards and specifications to support data integration, analysis, and reporting
Provide guidance in setting up infrastructure for external data flow into company clinical data pipelines
Oversee the validation of all third-party data generated in clinical trials, ensuring accurate integration into company clinical data pipelines
Develop strong and productive working relationships with key stakeholders, including Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members
Support submission readiness efforts and may represent the Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits
Represent the company in interactions with key external partners as part of the CT3 Third-Party Data Acquisition team
Ensure timely submission and ongoing maintenance of study-related third-party data acquisition documentation in the Trial Master File (TMF)
Adhere to procedural documents and participate in their review and updates to ensure compliance with industry standards, regulatory requirements, and best practices
Collaborate with and review work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services on behalf of the company
Escalate issues to CT3 leadership as needed
Qualification
Required
Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout activities
Create external data transfer agreements, ensuring alignment with company standards and specifications to support data integration, analysis, and reporting
Provide guidance in setting up infrastructure for external data flow into company clinical data pipelines
Oversee the validation of all third-party data generated in clinical trials, ensuring accurate integration into company clinical data pipelines
Develop strong and productive working relationships with key stakeholders, including Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members
Support submission readiness efforts and may represent the Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits
Represent the company in interactions with key external partners as part of the CT3 Third-Party Data Acquisition team
Ensure timely submission and ongoing maintenance of study-related third-party data acquisition documentation in the Trial Master File (TMF)
Adhere to procedural documents and participate in their review and updates to ensure compliance with industry standards, regulatory requirements, and best practices
Collaborate with and review work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services on behalf of the company
Escalate issues to CT3 leadership as needed
Strong working knowledge of FDA and ICH regulations, industry standards, and quality control principles
Experience across all phases of drug development
Extensive experience in clinical data acquisition and management from external/third-party vendors
Ability to lead study-level negotiations and agreements for data transfer or integration on behalf of the company
Strong collaboration skills, with the ability to work effectively across all levels of the organization with moderate supervision
Preferred
Familiarity with FTP tools like GlobalScape and clinical platforms such as Veeva CDMS, Elluminate, and Veeva TMF is a plus
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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