Clinical Operation Project Lead

Summary This role is responsible for leading all Global Clinical Operations for Gan & Lee Pharmaceuticals USA Corporation (Gan & Lee Pharmaceuticals USA) which includes leading the development planning launch conduct closure and submission of sponsored clinical trials in accordance with all applicable federal state and local laws/regulations and Companys policies procedures and guidelines. The Clinical Operation Project Lead is the global clinical operations representative and is accountable for the strategic planning and overall management of clinical program implementation and execution. Education and Credentials

• Bachelor of Science degree in scientific field or equivalent required.

• Advanced degree (Masters PhD or equivalent) in a relevant field preferred.

Experience

• Minimum 10 years direct pharmaceutical industry experience in clinical operations with a masters or doctorate level degree.

• Minimum 15years direct pharmaceutical industry experience in clinical operations without an advanced degree

• Proven track record of managing multinational clinical operations teams and cross-functional collaboration.

• Experience in vendor/CRO selection negotiation and oversight.

• Project Experience in chronic disease required.

• Project Experience in endocrine or metabolic disease is highly preferred.

Skills

• Must have well-developed communication skills (both oral and written) and be able to work effectively in cross-functional teams both internally and externally to the organization.

• Proficient in Microsoft applications including Word Excel Project and PowerPoint.

• Demonstrated working knowledge of the principles of drug development.

• Demonstrated ability to oversee/manage multiregional clinical trial(MRCT).

• Demonstrated capacity to contribute to study design.

• Proficiency in GCP and ICH regulations.

• Efficient organized and capable of prioritizing multiple tasks.

• Willingness to adapt to changing priorities and assignments.

• Strong attention to detail.

• Knowledge in the Diabetes/Endocrinology and Oncology Therapeutic areas preferred.

• Experience supporting regulatory submissions preferred.

• Experience with Vendor Management.

Responsibilities

• In accordance with all applicable federal state and local laws/regulations (including local/regional regulations outside US as required) the Companies policies procedures and guidelines. This position is responsible for ensuring quality and compliance in all actions by:

• Responsible for oversight of direct and indirect reports including budget estimates for business planning purposes and new opportunities.

• Exercising the highest level of integrity in all tasks performed.

• Embracing a behavior of employee involvement and commitment to doing the job right the first time.

• Collaborates in the operational design and conduct of clinical studies sponsored by Gan & Lee Pharmaceuticals USA from protocol feasibility through database lock study report generation and submission activities.

• Provides leadership for the timely planning implementation and conduct of clinical study-related activities including the development of study-specific documents such as protocols and amendments informed consent forms status update reports and training materials.

• Review/approve clinical trial agreements transfer of obligations purchase orders site contracts.

• Evaluates/selects qualified vendors and investigators; generates a request for proposals (RFP) with vendors.

• Oversees the progress of studies and performance of vendors (including CROs) on a continual basis through a review of communication and monitoring plans review of monitoring visit reports maintenance of study progress via electronic data entry resolution of queries SAE review and reconciliation.

• Tracks key performance indicators for CROs; oversee the development of CRO Oversight plans as needed.

• Ensures all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure patient safety quality data and accurate study timelines budgets and quality standards are met.

• Ensures Trial Master Files are proactively managed by the Study Managers and Associates by performing periodic visual inspections against the TMF index

• Oversees study timelines including key milestones. Identifies and manages critical path activities; anticipates bottlenecks and ensures contingency plans are in place and negotiated with the CROs to mitigate risk. Help team identify and address system or process issues hindering the delivery of high-quality data results within the specified study timelines.

• Oversees development negotiation and management of clinical trial budgets ensuring all out-of-pocket spending is accounted for and tracked. Oversees the tracking of clinical budgets to ensure payments are made in a timely manner (ie at the time key deliverables/milestones are achieved). Participates in quarterly financial updates (planned vs actual budget forecasting).

• Oversees subject recruitment and retention. Oversees development of enrollment plan risk mitigation site recruitment strategies.

• Oversees development of protocol-specific documents required for registry/posting of clinical studies on public registries. Ensures Study Managers and Associates provide timely updates to public registries.

• Approves invoices from vendors in order to ensure timely disbursement of payment and compliance with contracts and study budgets.

• Apprises Senior Management of any crucial study-related issues that arise. Participates in the generation of corrective and preventative action plans to address issues.

• Collaborates in the writing of Clinical Study Reports Investigator Brochures and regulatory submission documents.

• Acquires clinical knowledge of the therapeutic area(s) and compounds under development. Acquires working knowledge of global regulations and guidelines as it pertains to clinical research.

• Forecasting and coordination of clinical and non-clinical supplies requests and reviews drug label and kit designs.

• Liaison between CRO and Gan & Lee Headquarters regarding all IP Imports and Exports for all assets and provides all required documentation for shipments.

• Provides operational input into the development plans for new and existing products.

• Ensures study compliance to Gan & Lee Pharmaceuticals USA quality standards/processes and GCPs.

• Provides leadership for Global Clinical Operations department establish and manage a multinational clinical operations team to support the preparation and implementation of global clinical operations projects.

• Ensuring employees under the scope of responsibility are trained in required procedures for the execution of their role and maintain current training requirements during the year.

• Leads team with purpose provides coaching mentoring and real-time feedback ensures sufficient/appropriate training conducts bi-annual performance reviews engages in transparent and constructive conversations and provides appropriate professional development.

• Champions operational excellence to provide continuous improvement of processes and sharing of best practices/lessons learned. Facilitates effective decision making. Contributes to departmental process improvements.

• Proposes alternative study operation strategies to optimize use of time cost and resource.

• Anticipates resource requirements to support business plans and directs/oversees the on-boarding of new hires vendors etc.

• Identifies prioritizes allocates and manages appropriate resources in order to successfully achieve business strategy objectives.

• Advises management on issues related to Clinical Operations that could jeopardize the successful implementation of strategic business plans.