Clinical Data Associate III

Clinical Data Associate III

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas:
Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Title:

Clinical Data Associate III

Duration: 6 Months

Location:

Foster City, CA 94404

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 Client 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, Biobanking 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.

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

2) Project management experience of clinical trials

3) Understanding of clinical data management processes

4) Communication with cross-functional study team members