External Data Acquisition Specialist

External Data Acquisition Specialist

Position Details

​​​ Location: Remote (Working EST hours)

3 rd party data clinical experience, GCP, SOP, compliance standards

Responsibilities:

Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.

Assist in creating external data transfer agreements, ensuring alignment with standards and specifications to support data integration, analysis, and reporting.

Provide support in setting up infrastructure for external data to flow into Clinical data pipelines.

Assist in validation of all 3rd Party Data generated in clinical trials into Clinical Data pipelines.

Develop and maintain working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.

Assist in preparing function for submission readiness and may support Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits.

Act as a representative of the client in interactions with key external partners as part of the CT3 3rd Party Data Acquisition team.

Support timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in TMF.

Follow procedural documents and assist in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements and include optimal processes.

Assist in liaising with and reviewing work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services on behalf of the client

Escalate issues to CT3 leadership as appropriate.

Technical/Functional Expertise:

Develop working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.

Gain exposure to all phases of drug development.

Assist in handling Clinical data acquisition and management from external/3rd Party vendors.

May support study-level negotiation and agreement for data transfer or integration on behalf of the client

Collaborate with all levels of employees with moderate supervision required.

Familiarity with FTP tools like GlobalScape, Clinical platforms like Veeva CDMS, Elluminate, and Veeva TMF will be beneficial.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.