Associate Director, Clinical Operations
Vor 2 Tagen
General Description (role may include some or all of the following_):
- Manage indirect and direct reports, external partners, consultants, vendors and budget to ensure the timely and cost-effective implementation of clinical trials.
- Provide leadership, guidance and direction to assigned staff, and ensure their growth and development.
- Manage assessment of CROs and preferred vendors for implementation of clinical development plan.
- Support the review and approval of contracts and/or work order changes prior to submission to senior management for approval.
- Establish and maintain effective communication and collaboration with functional area peers including Drug Safety, Quality Assurance and Regulatory Affairs, as well as thought leaders in order to meet program objectives and achievement of goals.
- Support quality practices and GCP Compliance ensuring the completeness and accuracy of the study synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure.
- Lead or support a clinical study and demonstrate a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities.
- Provide oversight of clinical studies, including manager and associate members of Clinical Operations, strategic partners, CROs and other vendors, to ensure study plans, timelines, and budgets are aligned with study objectives and standards.
- Demonstrate a strong understanding of methodologies and may initiate, lead or support process development to improve effectiveness of Clinical Operations.
Important functions of the job (_role may include some or all of the following_):
Quality
- Support the development of initiatives, including acting as lead on the development /definition of certain SOPs and processes.
- Ensure necessary Clinical Operations and cross-functional quality plans are in place and being adhered to.
- Provide oversight and guidance to team on managing the creation, maintenance and close out of TMF activities.
- Ensure Clinical Operations team are trained and adhere to required processes and SOPs.
Timelines
- Ensure the coordination of relevant and timely exchange of information / materials e.g. patient enrollment, site selection, data collection, with other BeiGene functions (primarily the CST) to support clinical study delivery.
- Support the clinical study managers as needed to ensure timely and efficient database lock e.g. by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts, oversee query resolution, ensuring it is completed according to study specifications and that sites are responsive to vendor to meet the deliverable.
Budget
- Liaise with strategic clinical sourcing when needed to ensure that external partnerships e.g. CRO, are effectively supporting clinical trials, within contracted terms including budget.
- Oversee administration of invoice reconciliation, scoping, and change orders, for clinical trial operations.
Planning/Leadership:
- Lead or support managers in Clinical Operations with clinical study management; include risk management and problem-solving.
- Lead of support managers in Clinical Operations to ensure clinical studies are operationally feasible; include risk management and problem-solving.
- Proactively identify, negotiate and broker solutions on clinical study issues.
- Delegate and oversee certain aspects of the study management to ensure clinical studies are executed within specified time, quality and cost parameters.
- Be escalation point person and escalate issues as appropriate.
Supervisory Responsibilities:
- Ensure the competencies and skills required for Clinical Operations team is consistent with the company defined requirements.
- Mentor team members to support clinical development by delegating responsibilities, overseeing and supporting development plans.
- Conduct mid-year and year end performance appraisals for direct reports which includes providing constructive feedback.
Education Required:
- Bachelor’s degree or higher in a scientific or healthcare discipline
General Requirements:
- Minimum of 10 years progressive experience in clinical operations, preferably within the biotech/ pharmaceutical sector
- Relevant leadership and management experience
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Other Qualifications: Strong written and verbal communication skills
Travel: May be required (estimate 10% - 15% on average)
Competencies:
Ethics - Treat people with respect; Inspire the trust of others; Work with integrity and to high ethical standards; Uphold organizational values.
Planning/Organizing - Able to prioritize and plan work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Sp
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