Clinical External Data acquisiton Lead/Manager - Hybrid

Job DescriptionJob Description

 3rd Party Data Acquisition Lead/Manager 

Job Description:

·         Serving as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level, managing study start up, conduct and close out activities.

·         Creating external data transfer agreements, ensuring external clinical trial data are in alignment with the Takeda Standards and specifications to support data integration, analysis, and reporting.

·         Help and advice in setting up infrastructure for external data, to flow into Client’s Clinical data pipelines.

·         Responsible for validation of all 3rd Party Data generated in clinical trial into Client’s Clinical Data pipelines.

·         Developing strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards and other Study Execution Team members. 

·         Participates in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.

·         Representing Client in interactions with key external partners as part of Client’s CT3 3rd Party Data Acquisition team

·         Responsible for timely submission and on-going maintenance of study related 3rd Party Data Acquisition documentation in TMF

·         Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.

·         Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing services on behalf of client.

·         Escalating issues to CT3 leadership appropriately

Technical/Functional Expertise

·         Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.

·         Experience with all phases of drug development.

·         Solid Experience in handling Clinical data acquisition and management from external/3rd Party vendors

·         May lead study level negotiation and agreement for data transfer or integration on behalf of Client.

·         should be able to function collaboratively (with some guidance) with all levels of employees , moderate supervision required

·         Knowledge on FTP tools like GlobalScape, Clinical platforms like Veeva CDMS, Elluminate and Veeva TMF will be a plus.

Location: Lexington, MA

Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.

Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r\n\r\nOur popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.