PRA Health Sciences
Telecommute – US National
Title: Biomarker Data Specialist II
Location: United States
As a global top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full-service clinical development to the pioneering Embedded Solutions model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 18,000 employees who speak more than 30 languages, spanning 13 time zones across six continents ? yet who operate in unison as one worldwide PRA community.
We are hiring for an experienced Biomarker Data Manager, this is an excellent opportunity for career development as our company continues to grow.
This particular role is to be part of a dedicated Data Management team working for an embedded client, a global Pharmaceutical company.
Our motto: One client! One team! One set of processes to learn!
Why join SSD Biometrics?
PTO policy is very competitive
Employee Stock Purchase Plan
Significant return rate of PRA ex-employees
Get involved in client initiatives, process improvements, investigator meetings, training, mentoring?..break out of the day-to-day
See the results of your work through direct discussions, meetings, townhalls and teambuilding events with client leadership
Upward mobility for those that are interested ? our SSD leadership structure is primarily built from within and have been in place with us for 5, 10+ years!
High retention of team members and management means stable teams and positive program culture
Permanent PRA employees with examples of opportunities to convert to client perm roles
Significant global industry conference participation, SCDM, JSM, PhUSE, PharmaSug, DIA.
The Biomarker Data Specialist II (BDS II) is responsible for oversight of clinical specimens and associated laboratory data collected throughout the life of a clinical trial, including safety labs, PK, biomarkers, tumor samples, etc. with minimal supervision. Responsibilities include collaborating with cross-functional teams to plan, develop and execute lab-related aspects of a clinical trial. A BDS II will oversee the following: clinical specimen plans and associated tools in support of study startup/amendments, sample tracking and handling, external lab data transfers, and reconciliation of vendor data with clinical data. They will manage operational plans and timelines related to data deliverables and locks. Additionally, they will support laboratory vendor evaluations and startup, development and review of study protocols and scientific oversight of analytical laboratories. The Biomarker Data Specialist II has an understanding of clinical laboratory and biomarker testing typical in an oncology setting and is adept at handling specimens and lab data. They also possess a working knowledge of FDA regulations and general industry standards.
Independently oversee laboratory specimen management and data management procedures. Utilize templates and standard guidelines to initiate documents but exercise critical thinking and discretion to tailor documents to study needs.
With minimal oversight, manage multiple project streams, each with their own timelines, objectives and deliverables with minimal oversight.
Advise and coordinate with clinical project managers, scientists, external vendor contacts, programmers, analysts and other stakeholders regarding timelines and deliverables.
Manage and resolve complex problems that require in depth evaluation, while balancing multiple stakeholders…
Medical & Health , Medical Research , Pharmaceutical