Director, Biospecimen Data and Operations

The Director of Biospecimen Data and Operations (BDO) will oversee the Biospecimen Data and Operations function to enable sponsors to use Slope software to meaningfully improve the performance of their clinical trials. This includes ensuring sponsors, labs and research site end-user success and satisfaction through the proper setup, execution, and closeout of clinical studies.

Key responsibilities include:

• Strategic Leadership: Provide direction to align biospecimen operations with sponsor goals, ensuring seamless execution and optimal outcomes.
• Client Relationship Management: Build and maintain strong client relationships, offering high-level expertise and guidance on Slope software.
• Sponsor and Site Satisfaction and Customer Success: Oversee study progress, address high-level concerns, and implement strategies for client success.
• Leadership and Collaboration: Lead and mentor the BDO team, and serve as the primary contact for select clinical trials.
• Program and Initiative Management: Manage high-impact initiatives, ensuring timely delivery and high-quality results.
• Cross-Functional Coordination: Lead and coordinate internal and external resources, including integration partners, to ensure effective cross-functional collaboration and delivery of Slope platform capabilities.
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Ideal candidates will possess a comprehensive background in biospecimen lifecycle, data management, central labs, third-party testing labs, and related operations. They will be skilled in project management and committed to delivering high-quality service and support to clients throughout their clinical trials.

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• Manage strategic and day-to-day operations of the BDO team.
• Act as a primary contact for clients, ensuring seamless execution of translational services within integrated precision solutions, encompassing study logistics, kitting, assay development, clinical sample testing, biomarker data management, and informatics.
• Provide oversight and leadership to BDO Program Managers, Slope client services, and channel partners through a matrix organizational structure.
• Manage contracts and oversee execution of Slope core services to ensure proper Slope platform utilization.
• Assist in finalizing proposals, budgets, and contracts.
• Plan and organize projects to ensure timely service delivery, collaborating with BDO Program Managers and technical leads from Slope’s product and sales leadership teams.
• Serve as the initial point of escalation.
• Define and achieve departmental goals and metrics for BDO.
• Develop, implement, and optimize business processes to enhance delivery efficiency of the Slope platform and client services.
• Support the development and deployment of study dashboards, monitor performance, and report on key business metrics.
• Report project updates, risks, and success metrics to executive leadership.
• Ensure customer success by establishing clear success criteria for each trial managed directly or by BDO Program Managers.
• Other duties as assigned.

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Education

Bachelor’s degree or equivalent work experience (preferability in life sciences, biotechnology, clinical research, or data management).

Experience

• Minimum of 5 years of biospecimen/clinical/biomarker data management, clinical trial project management, or related experience.
• Minimum of 5 years of management experience with electronic data capture (EDC) systems, lab information management systems (LIMs), including database builds, data flows and related data governance.
• Experience with complex and multi-phase (Phases 1-3) clinical trials.
• Extensive experience with sample tracking, data reconciliation, and lab vendor operations.
• Experience collaborating with central labs, third-party testing labs, clinical research organizations and sponsors.

Knowledge, Skills & Abilities

• Expertise in clinical trial management, data management principles, and biospecimen operations, including process flow and risk mitigation strategies.
• In depth knowledge of and contribution to clinical research protocols, lab manuals, data transfer specifications, requisition form design, and data management plans.
• Familiarity with regulatory requirements and industry standards for biospecimen handling and data management.
• Strong understanding of lab setup processes and data capabilities.
• Proven leadership in managing teams, mentoring junior staff, and leading training.
• Excellent client management skills.
• Excellent analytical, time management, organizational, and project management skills.
• Strong verbal and written communication skills, with excellent interpersonal abilities.
• Detail-orientation with strong problem-solving skills.
• Strong project management practices and high-level computer and technology proficiency.
• Ability to provide a high-level of customer service and guidance for clinical trials.

Preferred Qualifications

• Master’s degree in clinical research, life science, or data science.

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Slope's clinical trial execution platform orchestrates the entire biospecimen lifecycle from kitting to testing at the lab, providing sponsors with accurate, real-time biospecimen data needed to inform timely study decisions. Slope captures sample data directly from sites as they perform study activities and integrates with EDC, RTSM, LIMS, labs, kitters, and shippers, ensuring seamless data flow and trial execution for all stakeholders. Slope's software provides sponsors with instant access to higher-quality sample data, leading to faster reconciliation, less risk, and significantly improved study compliance, monitoring, and reporting. Slope has supported thousands of the most complex, sample-intensive trials worldwide and has been adopted by over 75% of NCI-designated cancer centers for inventory and sample management. For more information, visit slopeclinical.com.

Slope has a fun, high-energy, fast-paced environment full of motivated, purpose-driven employees who practice our core values on a daily basis:

1. Patients are paramount
2. Better, faster, stronger
3. Driven by data
4. Job done, have fun
5. Get Sloped!

• Health insurance
• Dental and vision coverage
• Flexible spending accounts
• Healthcare savings accounts
• Employee-funded supplemental life insurance
• Employee-funded short and long-term disability insurance
• 401(k) plan
• Nine paid holidays
• 15 PTO days
• Annual home office stipend