Clinical Data Associate

Company Description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

Lead clinical data manager with 3 -5 years of Sponsor or CRO or Academic experience

Project management experience of clinical trials

Understanding of clinical data management processes

Communication with cross-functional study team members

Specific Responsibilities:

This role will immediately assume biomarker data management responsibilities for representing biomarker data management at the biomarker Sub Team (BST) meetings. The candidate will also be responsible for providing oversight to studies that fall within the BSTs.

The selected candidate will manage biomarker data in various stages, from planning, to set-up, conduct, closeout, and archiving, in high volume, while maintaining a high level of data quality by leveraging and adhering to standard data structures and corresponding standard edit checks and review listings. The selected candidate may also manage and lead in the design and implementation of biomarker data management processes with vendors, ensuring completeness, correctness, and consistency according to the standards.

This role has a high degree of collaboration with the Biomarker cross-functional team members, study team members and other biomarker Clinical Data Associates.

The ideal candidate should possess a BS degree or higher in a Biomedical Science or equivalent and minimum 3 years of relevant clinical data management experience and preferably along with biomarker or laboratory background and experience in a CRO or bio/pharmaceutical setting.

Essential Duties and Job Functions:

Works collaboratively with Biomarker Clinical Operations team members, Biomarker Scientists, Biomarker Statistical Programming group, Biomarker Biostatistics group, Biomarker Clinical Programming group, Bio banking and Sample Management group, and lead study clinical data associate and cross-functional study team members to meet project deliverables and timelines for biomarker data acquisition, quality checking and reporting. Demonstrate a general understanding of each assigned protocol, critical tasks and milestones.

Ensure completeness, correctness and consistency of routine clinical data and data structure.

Responsibilities include: assisting in the developing the data transfer specifications, the data mapping specifications, the data quality review plan and the data validation specifications, vendor management, data review and data reconciliation. Assist in implementing routine clinical research projects and standards. Identifies, tracks, and resolves routine queries. Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met.

Knowledge, Experience and Skills:

3 years of experience and a BS degree.

1 year of experience and a MS degree or PhD.

Qualifications

Additional Information

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.

Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - (650)-399-0891

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)