Principal Sample Operations Lead
This position reports to Associate Director, Sample Operations Team Lead. As an integral member of Clinical Trial Business Partnerships, the Principal Sample Operations Lead is the process gate keeper and expert related to clinical sample management processes. The Pr. Sample Operations Lead will be asked to efficiently and independently perform the duties and responsibilities for this role
- Identifies and monitors program-level and therapeutic area-level clinical sampling standards.
- Translates protocol-level sample needs into clearly defined deliverables in support of study start up with clinical sites and laboratory vendors.
- Understands clinical team needs and communicates alignment with program testing strategy and escalates to the Biomarker Operations Lead for the program where there are areas of departure from established standards or recommended guidelines.
- Partners across the program and protocol team to ensure sample management needs are clearly understood and able to be contracted in accordance with BMS policy.
- Develops sample collection instructions for sites as needed to ensure clarity, quality and promote compliance. Supports the site/investigator training for proper collection techniques, time point requirements, and sample handling to ensure viability, integrity and data reliability. Develops and maintains sample collection instruction templates. Maintains knowledge of existing and new regulatory guidance as it pertains to clinical sample management. Partners with site-facing roles to ensure compliance on sample management areas like processing instructions and applicable regulations/guidance to promote integrity of research samples. Advices on proper documentation and/or resolution on sample management issues.
- Partners dynamically with clinical teams, translational medicine enabling solutions, vendor management, outsourcing management and global procurement to drive the strategic BMS position to enhance the value of preferred partners' capabilities to BMS through early engagement and risk management with internal teams as well as our preferred labs, cross-organizational discourse and planning transparency.
- Manages and owns study start up process with central laboratory vendors, including performance and issue escalation.
- Supports escalation of sample management concerns during the execution of a protocol. Ensures all issues are logged, advises on mitigation and remediation of issues, escalates issues and drives to closure in support of team goals and timelines. Partners with Vendor Alliance leads to escalate systemic issues.
- Supports biomarker and pharmacokinetic/immunogenicity sample tracking; assessing requirements, collaborating with internal and external partners for clarification and escalating issues to the clinical team as needed.
- Manages and drives sample shipment management originating from central laboratory partners.
- Supports the creation of documentation related to sampling strategies and updates at each DP (or ad hoc as necessitated by scope/nature of changes to previously established standards) by providing valuable participation for critical sample strategy meetings including internal and external engagement meetings.
- Demonstrates good communication and interpersonal skills; leverages those competencies to ensure continuous progress of internal and external teams thus moving issues to resolution.
- Actively maintains a Book of Work for the Sample Operations Lead organization as well as effective management of their individual BOW; ensuring protocol status and resource demand are updated for management assessment on a monthly basis.
- Maintain personal and organization monthly time metrics in support of protocol startup and execution in order to aid senior management review of overall drug development costs.
- Participate as internal SME in Due Diligence efforts for third-party Specialty Labs to ensure that specialty lab operations are functioning with an appropriate internal control environment, and meeting expectations of relevant regulatory requirements as dictated by the nature of the work entrusted to their execution as required.
- Actively serves as a liaison to other strategic and process improvement initiatives across internal and external organizations.
- Provides explanation and/or feedback on sample management related findings for all internal and external site audits, follows up corrective and preventative actions to completion and implementation.
- Fosters teamwork between BMS functional areas; creating a team environment based on mutual trust and respect. Encourages teams to share knowledge, experiences, best practices, and information on an ongoing basis.
- Bachelor's degree is required and/or project management certification is desirable. Advanced degree a plus
- Minimum 5+ years of Clinical Development experience is required. Coaching and mentoring experience a plus.
- Knowledge of clinical biospecimen procedures including: collection and tracking procedures, logistics considerations, chain of custody, issue escalation/resolution and data management highly desired.
- Strong and effective management of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
- Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate.
- Proven ability to proactively anticipate and mitigate issues with strong analytical skills to arrive at logical solutions.
- Ability to work independently with minimal consultation.
- Proven time management skills and ability to be flexible to meet job demands and take on new initiatives and improvement efforts
- Proven ability to sustain high levels of performance in a constantly changing environment.
- Strong written and oral communication skills with experience in developing training and/or informational material and presenting to both internal and external stakeholders.
- Experience and advanced fluency with MS Office tools (esp. MS Excel, MS PowerPoint and MS Project).