Biospecimen Operations Manager
Job Description
Essential Functions of the Job (Key responsibilities)
Qualifications (Minimal acceptable level of education, work experience, and competency)
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
- Play a key role in the communication and integration of translational medicine objectives with clinical study team members during protocol development and execution.
- Serve as a member of the Translational Medicine clinical study start team;support the tactical execution of biospecimen collection and analysis during clinical protocol development, study start-up and amendments, including contribution to and review of protocols, lab manuals, and clinical laboratory documents and communicate information as required to other departments and CROs (if appropriate);take part in program meetings with central lab, clinical, operations and data management.
- Contribute to activities involving the Data Management team, including eCRF set-up, database build for sites and sample tracking/reconciliation.
- Particpiate in efforts to standardize nomenclature, pictograms, sample handling instructions, and resources for all central labs to ensure consistency across studies, welcoming diverse perspectives, and inclusive practices.
- Coordinate with others within Translational Medicine group and external to the group to track and manage samples, projects, and deliverables.
- Aid in the process development and coordination of informed consent form tracking and clinical program sample storage/tracking using in-house and commercial systems.
- Participate in vendor meetings to stay informed of current and upcoming projects, innovative technologies, and vendor offerings.
- Solve problems independently, contacting internal or external clients as needed, while fostering a collaborative and inclusive environment.
- Must be able to prioritize workload in response to the specific needs of numerous protocols and department.
- Maintain awareness of local and international regulations as pertains to protecting the privacy of personal information that may be associated with clinical samples.
- Participate in process improvement initiatives. Plan and implement procedures and systems to maximize operating efficiency.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Scientific background (BS, RN, Med Tech) with a minimum of 2 years experience in clinical drug development, clinical trial execution, central lab study setup with exposure to biomarkers, pharmacokinetics or immunogenicity sample activities including sample collection procedures and logistics considerations, and exposure to informed consent language specific to the handling of human tissue specimens
- An understanding of the drug development process and familiarity with clinical labs and clinical trial sites
- Experience working with Contract Research Organizations (CRO)
- Demonstrated knowledge of ICH and GCP
- Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems and controlled sample management systems
- Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues.
- Excellent teamwork and ability to collaborate with cross functional teams.
- Strong interpersonal, written, and verbal communication skills
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
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