Clinical Operations Manager, Biosample Operations (Clinical Trial Operations) - Remote New Jersey

Orbis Clinical is seeking a remote-based Manager, Bio Sample Operations for 12 months.

Job Title: Manager, Biosample Operations

Location: Remote

Contract: 12 months

Duties:              

This role is expected to work in close collaboration with several cross-functional stakeholders including but not limited to Development Operations, Research and Development, Biometrics, and Clinical Study Teams

In collaboration with the Clinical Study Team, support selection, management, and oversight of vendors for services such as central safety labs and specialty testing labs (e.g., bioanalysis, and/or microbiology)

Support the planning and coordination of bio-sample activities required to manage the quality and lifecycle of biospecimen samples (e.g., collection, shipping, processing, analysis, data delivery and cleaning, long term storage and final sample disposition)

Review the CRO partner Clinical Laboratory Specifications (CLS) to ensure lab database is designed according to protocol specifications

• Chain of Custody – Responsible for performing near real-time bio-sample tracking for assigned clinical trials in close collaboration with the Laboratory, the Clinical Study Teams, and CROs
• Lead the gathering, analyzing, and interpretation of reports from CRO partner, EDC databases, central lab databases, and specialty lab databases to align data into tracking tools
• Support identification, implementation and maintenance of sample tracking tools
• Oversee CRO partner sample management activities per study level including sample tracking, site escalations, query resolution, and lost samples
• Support resolution of bio-sample related data reconciliation issues at sites or analysis labs in collaboration with relevant stakeholders including Data Management, Development Operations and CRO partners
• Responsible for providing timely updates and coordination of sample movements needed for analysis or long-term storage to key stakeholders including Development Operations and the Clinical Study Team
• Support ongoing inventory reviews and work with the appropriate stakeholders to obtain approvals for disposal/transfer of samples in long-term storage facilities
• Support clinical study teams on technical and operational sample-related questions and/or escalations
• May assist the Clinical Study Team with the management of clinical supplies and equipment distribution to all clinical sites, including coordination with internal and external stakeholders as necessary.
• Assists, as needed, with financial management of vendors, including invoice reconciliation, budgeting, monthly/quarterly accruals, and variance reporting for vendor contracts as needed.
• Process Documentation and Improvement – Support review of study documents that pertain to bio-sample collection, handling, and storage including clinical study protocols, ICFs, and lab manuals
• Participate in Protocol and CRF development to ensure laboratory sample information is collected for sample tracking and reconciliation purposes
• Support resolution of informed consent and IRB/EC questions related to bio-samples in collaboration with Development Operations and the Clinical Study Teams
• Support development and update of SOPs and guidance documents to support bio-sample management activities
• Work cross-functionally with stakeholders to identify when a process revision is required
• Ensure appropriate performance and quality targets are established (via metrics and KPIs) and oversight is maintained to understand target realization
• Evaluates metrics and Key Performance Indicators (KPIs) to ensure oversight of clinical trial progress and performance.
• Provides support to clinical operations team for laboratory vendors across multiple study protocols.
• Participates in investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
• Works directly with investigational sites to answer questions, train, and serve as liaison with vendor(s) to ensure issues are escalated and addressed thoroughly and quickly.

Skills:

•  Minimum of 5 years’ experience working in clinical research setting with a Sponsor/CRO company required.
• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials is required.
• Experience in clinical trial conduct in multiple phases of development across several therapeutic area preferred.
• Strong leadership and project management skills, demonstrate flexibility and agility working within a multi-functional, global matrix
• Must have excellent communication skills (verbal and written), and good interpersonal/group skills.
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Individuals must demonstrate an ability to interact successfully in a dynamic and culturally diverse workplace
• Roll-up-your-sleeves orientation and a strong ability to work in a team-based environment.
• Must successfully exhibit company’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.

Education:     

• Bachelor’s degree is required.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $88.50 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.