[Remote] Associate Director, Clinical Operations

Note: The job is a remote job and is open to candidates in USA. BBOT is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for cancer treatment. The Associate Director of Clinical Operations will lead clinical trial activities, manage study teams, and ensure compliance with regulatory standards while maintaining relationships with investigators and vendors.

Responsibilities

• Study Planning and Management
• Accountable for overall management of clinical trials, including providing strategic direction to the study team, to meet corporate goals and timelines
• Collaborate with the Clin Development to assess study progress, ensure proper study conduct and adherence to the protocol
• Central role maintaining relationships with other internal functions, strategic partners and CROs
• Oversee functional deliverables to support program objectives, identify risks to study timelines, propose mitigations, and implement solutions with team and management support
• Communicate program status, cost, and issues to senior management
• Daily activities may include updating / reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, study plans, etc.), monitoring study status, evaluating and keeping in place a suitable resource plan, anticipating and mitigating risks within the timeline, quality and cost paradigm
• Monitor global regulatory intelligence for international industry practices for operational efficiency and compliance
• Responsible for the coordination of team meetings, as assigned, with both internal and external partners
• Serve as a clinical trial lead for one or more trials and responsible for implementation, planning, and execution of clinical trial activities
• Cultivate and maintain strong relationships with investigators, and trial site managers and other site staff, as applicable
• Participates in the selection of vendors and manages their activities
• Organize investigator meetings, as needed
• Coordinate timely data review to identify trends and discrepancies
• Responsible for all aspects of site management from feasibility, selection, start-up, maintenance, and close out
• Select, assess, and approve sites for activation
• Contribute to study budget, including regular forecasting and internal reporting
• Review invoices against scope of work and work completed to date, and to identify and communicate variances
• Provides critical deliverable, milestone feedback and other as needed input in contract negotiations
• Responsible for management of CRO and vendors to support clinical operations contracted for the assigned study/studies
• Oversee vendor performance by developing positive partner relationship, responsible for identifying risks issue resolution and first line of study team governance
• Responsible for deliverables are per budgets and agreed upon timelines
• Responsible for reviewing and approving invoices from study vendors
• Works intimately with internal and external Teams (DM, Bio Stat, contribution functional areas) on the overall development and maintenance of a study EDC to ensure that all necessary data is captured to achieve study objectives
• Lead activities related to clinical data review/query resolution; ensure consistent quality data review
• Contribute to the testing of EDC
• Contribute to development, training, implementation, and monitors compliance of Standard Operating Procedures
• Provide active support with the development, implementation and continued maintenance of quality control processes and workflows to ensure that all clinical trial activities are compliant with Good Clinical Practices and applicable regional regulatory guidelines
• Acts as liaison for Clin Ops between the sites and study team for audits on an ongoing basis
• Lead Clin Ops aspects of inspection readiness activities and act as an expert during regulatory inspections
• Responsible for ensuring the coordination and planning, working with Clinical Supplies, for availability of clinical and non-clinical supplies at sites (drug supplies, and other required materials critical for study conduct)
• Manage, direct, and mentor junior members of the Clinical Operations team, as applicable
• Other duties as assigned

Skills

• BA/BS required in a scientific / medical field, or equivalent work experience
• 8- 10 years of industry experience
• Demonstrated ability to successfully manage and support clinical trial deliverables from start-up through close-out, including all financial tracking and reporting activities
• Understanding of clinical trial design, protocol development and review
• Extensive experience with cross-functional leadership and clinical teams, including data review, database lock and study reporting activities
• Vendor management experience required given many accomplishments will come from external resources
• Experience in maintenance of a submission ready eTMF required
• Experience in Quality Assurance, SOP (Standard Operating Procedure), and study plan writing, CAPA (corrective and preventative action) preparation and closure
• Experience with investigator-initiated and industry-sponsored studies
• Strong knowledge of GCP (Good Clinical Practice) and working knowledge in ICH (International Conference on Harmonization) GCP (Good Clinical Practice) E6 R2 regulations
• Knowledge of GDPR (General Data Protection Regulation) and how to apply appropriate practices to clinical trials
• Leadership ability and further potential to build relationships in a matrix environment, ability to multi-task in a dynamic and fast paced environment
• Excellent interpersonal, written, and verbal skills required
• Working experience / knowledge of timeline management tools (e.g., Smartsheet)
• Position title based on experience, capabilities and demonstrated competencies
• Experience in oncology studies is preferred

Benefits

• Annual bonus
• Stock-based long-term incentives
• Medical, dental, and vision benefits
• Retirement
• Wellness stipend
• Flexible time off

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