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Title: Senior Sample Operations Lead
Location: Pennington, NJ
Duration: 06 Months
The Central Clinical Planning & Solutions, Scientific Vendor Management & Operations department is focused on executing the business' sourcing strategy across all phases of R&D development operations. This group supports the management of clinical samples for early and late stage development assets, ensuring alignment to key development strategies and effective collaboration with Central and Specialty Labs. We provide sample-related protocol start-up operational support and guidance to teams and clinical sites on tactical requirements of specific clinical sample handling. This group also applies a common framework to drive efficient, consistent and compliant processes for vendor relationship and management of Client' major clinical service providers. Serving as a bridge between Client' clinical teams and external services providers, the Scientific Vendor Management & Operations group is responsible for building the appropriate in-house management/oversight structure and mechanisms, while driving the external collaboration with clinical service providers in effort to yield a multitude of innovative ideas to deliver on Client' goals.
This position reports to the Pr. Sample Operations Team Lead. As an integral member of Central Clinical Planning and Solutions, the Senior Sample Operations Lead is the process gate keeper and expert related to clinical sample management processes. The Senior Sample Operations Lead will be asked to efficiently perform the duties and responsibilities for this role as outlined below.
• Translates protocol-level sample needs into clearly defined deliverables in support of study start up with clinical sites and laboratory vendors. Understands 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 protocol team to ensure sample management needs are clearly understood and able to be contracted in accordance with Client 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.
• Partners with clinical teams, translational medicine enabling solutions, vendor management, outsourcing management and global procurement to drive the strategic Client position to enhance the value of preferred partners' capabilities to Client through early engagement with internal teams as well as our preferred labs, cross-organizational discourse and planning transparency.
• 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.
• Supports biomarker and pharmacokinetic/immunogenicity sample tracking; assessing requirement 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 his/her respective therapeutic area(s); ensuring protocol status and resource demand are updated for management assessment on a monthly basis.
• Maintain personal 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.
• Serves as SVMO liaison to other strategic and process improvement initiatives affecting his/her therapeutic area(s) as required and with appropriate consultation as needed.
• Fosters teamwork between Client 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.
• Life Sciences degree (Bachelor) required and/or project management certification is desirable.
• Minimum 3 years of Clinical Development experience is required.
• 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.
• Ability to proactively anticipate and mitigate issues with strong analytical skills to arrive at logical solutions.
• Ability to work independently with appropriate consultation as needed.
• Proven time management skills and ability to be flexible to meet job demands.
• Proven ability to sustain high levels of performance in a constantly changing environment.
• Effective written and oral communication skills with experience in developing training and/or informational material and presenting to both internal and external stakeholders.
• Experience and fluency with MS Office tools (esp. MS Excel, MS PowerPoint and MS Project).
Interested candidates can send their updated resumes on email@example.com and you can also reach me at 973-967-3431.
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