Clinical External Data Acquistion Lead

Maxis Clinical Sciences; Lexington (MA); On-site; USD 125,000 - 150,000; Full time

Job summary

An innovative firm is seeking a Mid-Senior level professional to lead the planning and acquisition of external clinical data in Lexington or Cambridge, MA. This role involves managing study start-up, conduct, and close-out activities while ensuring compliance with FDA and ICH regulations. The ideal candidate will have solid experience in clinical data management and the ability to collaborate effectively with various stakeholders. If you are passionate about improving health care through data-driven insights and have a knack for negotiation, this opportunity is perfect for you. Join a dynamic team and make an impact in the clinical research field!

Qualifications

• Strong understanding of FDA and ICH regulations is essential.
• Experience with clinical data acquisition from external vendors is crucial.

Responsibilities

• Manage study start-up, conduct, and close-out activities for external clinical data.
• Ensure alignment of external clinical trial data with Takeda standards.

Skills

Knowledge of FDA regulations

Clinical data management

Collaboration skills

Negotiation skills

Education

Bachelor's degree in a relevant field

Experience in drug development

Tools

GlobalScape

Veeva CDMS

Elluminate

Veeva TMF

Job description

Position Overview:

Replacement onsite in Lexington or Cambridge, MA. Open on compensation.

Responsibilities:

1. Serve 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.
2. Create external data transfer agreements, ensuring external clinical trial data align with Takeda Standards and specifications to support data integration, analysis, and reporting.
3. Assist in setting up infrastructure for external data to flow into Takeda Clinical data pipelines.
4. Validate all 3rd Party Data generated in clinical trials into Takeda Clinical Data pipelines.
5. Develop strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.
6. Participate in preparing functions for submission readiness and may represent the Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits.
7. Represent Takeda in interactions with key external partners as part of the Takeda CT3 3rd Party Data Acquisition team.
8. Ensure timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in TMF.
9. Follow procedural documents and participate in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements.
10. Liaise with and review work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services on behalf of Takeda.
11. Escalate issues to CT3 leadership appropriately.

Technical/Functional Expertise:

1. Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
2. Experience with all phases of drug development.
3. Solid experience in handling Clinical data acquisition and management from external/3rd Party vendors.
4. May lead study-level negotiation and agreement for data transfer or integration on behalf of Takeda.
5. Ability to function collaboratively (with some guidance) with all levels of employees; moderate supervision required.
6. Knowledge of FTP tools like GlobalScape, Clinical platforms like Veeva CDMS, Elluminate, and Veeva TMF is a plus.

Seniority Level:

Mid-Senior level

Employment Type:

Contract

Job Function:

Health Care Provider

Industries:

Strategic Management Services