Summary

This position reports to the Head of Clinical Operations,This role is responsible for leading the development, planning, launch, conduct, closure, and submission of Gan & Lee sponsored clinical trials in accordance with all applicable federal, state, and local laws/regulations and Company’s policies, procedures, and guidelines. The Senior Clinical Trial Manager will collaborate with other members of the Study Team for successful end to end excution and will take the operational lead on one or more studies. The role will be based in either Denmark or US.

Education and Credentials

• Minimum of a Bachelor of Science degree, preferably in Nursing, Pharmacy, or scientific field, or equivalent.
• Nursing/pharmacy license, in accordance with degree, preferred.

Experience

• At least 5 years of industry or equivalent experience with a master’s or doctorate level degree.
• At least 8 years of industry or equivalent experience without an advanced degree.
• Experience managing multiple complex global clinical trials.
• Demonstrated strong knowledge of the principles of drug development.

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 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 Weigh management Therapeutic areas will be seen as an advantage.
• Experience supporting regulatory submissions preferred
• Experience with Vendor Management .

Responsibilities

Under limited supervision and 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 the following:

• Ensure quality and compliance in all actions by adherence to strict compliance with procedures.
• Exercise the highest level of integrity in the tasks performed.
• Seek prompt identification, reporting, and correction of deviations in the workplace.
• Collaborate in the operational design and conduct of clinical studies sponsored by Gan & Lee from protocol feasibility through database lock, study report generation, and submission activities.
• Coordinate protocol reviews and approvals.
• Prepare study-specific documents in collaboration with CRO including informed consent documents (ICDs), status update reports, training materials. Participate in review of electronic case report forms (eCRFs), CRF completion guidelines, data management plans, statistical analysis plans, inspection readiness plan, monitoring plans, etc.
• Support preparation of Budget and Invoice Tracking, Forecasting, Monthly Updates to Senior Management, etc.
• Actively participate in the evaluation and selection of qualified external service providers (ESPs) (e.g., CROs), laboratory vendors, investigators, etc. and lead the contracting process with certain vendors which Gan & Lee contracts with directly. Communicate study specifications to CROs.
• Serve as the primary point of contact with certain CROs.
• Ensure Sponsor oversight by monitoring the progress of studies and performance of CROs on a continual basis through status update meetings, review of monitoring plan, review of monitoring visit reports, maintenance of study progress and more
• Ensure that 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.
• Oversee the set-up and maintenance of the Trial Master Files (with the CROs) in real time so TMFs are inspection-ready at any point in time.
• Manage study timelines including key milestones. Identify and manage critical path activities; anticipate bottlenecks and ensure contingency plans are in place and negotiated with the ESPs to mitigate risk. Help team identify and address system or process issues hindering delivery of high-quality data results within the specified study timelines.
• Oversee and track subject recruitment and retention. Oversee development of enrollment plan, risk mitigation, and site recruitment strategies. Coordinate the review/approval of study-specific recruitment materials.
• Generate and update protocol-specific documents required for registry/posting of clinical studies on public registries (clinicaltrial.gov). Secure approvals of these documents.
• Oversee development, negotiation, and management of clinical trial budgets, Clinical Trial Agreements and Letters of Intent. Support payment schedules against key deliverables.
• Approve invoices from vendors in order to ensure timely disbursement of payment and compliance with contracts and study budgets.
• Work collaboratively and cross-functionally (both internal and external to Gan & Lee ).
• Acquire clinical knowledge of the therapeutic area(s) and compounds under development. Acquire working knowledge of global regulations and guidelines as it pertains to clinical research.
• Forecast and coordinate clinical and non-clinical supplies requests in collaboration with CRO, review drug label and kit designs, initiate drug shipment, manage drug accountability, and review drug destruction/return policy.

Policies and Procedures:

• Ensure study compliance to Gan & Lee quality standards/processes and GCPs.
• Contribute to departmental process improvements.
• Provide leadership for specific departmental initiatives.
• Champion operational excellence to provide continuous improvement of processes and sharing of best practices/lessons learned.
• Facilitate effective decision making.
• Propose alternative study operation strategies to optimize use of time, cost, and resources.
• Manage critical changes and/or variance in financial forecast, schedule, scope, and deliverables.
• Provide mentoring for junior employees, interns, or consultants as appropriate.
• Perform other duties as required.

Powered by JazzHR