The Associate Director (AD) Clinical Study Management leads both indirect and direct reports, external partners, consultants, vendors and external budget to ensure the timely and cost-effective implementation of clinical trials. Provides guidance and direction to assigned staff, as well as ensuring growth and development of direct reports. This role assesses CROs and preferred vendors for implementation of clinical development plan and supports in the review and approval of contracts and/or work order changes prior to submission to senior management for approval.
The AD CSM establishes and maintains 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 support achievement of goals. Supports team with ensuring the completeness and accuracy of the study synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure. Leads or co-leads aspects of a particular clinical study and demonstrates a high level of knowledge of clinical operations' methodologies, organizational, project management and leadership capabilities and ensures alignment of clinical project goals with Clinical Operations program objectives. Collaboratively leads program initiatives to support Global Clinical Operations Development Operations expansion as an organization.
Essential Functions of the Job:
Quality
- Supports the development of department initiatives, including acting as lead on the development/definition of certain SOPs and processes.
- Ensures that an overarching trial cross-functional quality plan is in place.
- Provides oversight and guidance to team on managing the creation, maintenance and close out of TMF activities - e.g. manages Central Lab and ancillary vendors such as IVRS selection, set-up, conduct, and close-out for BeiGene studies.
- Adheres to Clinical Operations processes and SOPs.
Timelines
- Escalation point person to Program lead when necessary.
- Ensures the coordination of relevant and timely exchange of information/materials (e.g., patient enrollment, site selection, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development process.
- Supports COM when needed with timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review/reconciliation efforts, oversee that query resolution is completed according to study specifications and that sites are responsive to vendor to meet the deliverable.
Budget
- Liaises with strategic clinical sourcing when needed to ensure that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget; is the primary point of contact for CRO partners.
- Oversees the administration of invoice reconciliation, scoping, and change orders, for clinical trial operations.
Planning/Leading
- Supports COM with clinical trial management; ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity and the competitive.
- Leads cross functional team to ensure timely activation of clinical trials; including risk management and problem-solving.
- Proactively identifies, negotiates and brokers solutions to individual clinical study issues.
- Delegates and oversees the management of certain aspects of project management to COM or CTA staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters.
Supervisory Responsibilities
- Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements.
- Mentor junior team members to support 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.
Other Qualifications
- 8+ years progressive experience in clinical operations preferably within the biotech, pharmaceutical, and/or CRO environment.
- 5+ years proven leadership experience managing direct reports in a fast-paced, matrix environment and operating at the clinical development plan level, as well as experience in mentoring and influencing junior-level staff.
- Possess understanding of treatment landscape, standard of care, upcoming approvals, and good knowledge of KOLs and investigators.
- Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.
- Demonstrates a strong understanding of methodologies and approaches.
- Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.
- Proficient written and verbal communication skills.
- Proven experience collaborating effectively with the study team, cross functional team members and external partners (including investigator and site staff) using effective negotiation skills.
- Management experience of CROs, Vendors and Consultants preferred.
- Therapeutic or medical knowledge preferred.
- Regulatory authority inspection experience a plus.
Computer Skills
Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook.
Travel
May be required (10% - 15%).
#J-18808-Ljbffr
