Clinical Operation Project reputed company

Summary

This role is responsible for leading reputed company Global Clinical Operations for reputed company USA Corporation (reputed company, USA) which includes leading the development, planning, launch, conduct, closure, and submission of sponsored clinical trials in accordance with reputed company applicable federal, state and local laws/regulations and Company’s policies, procedures and guidelines. The Clinical Operation Project reputed company 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 (Master’s, PhD, or equivalent) in a relevant field preferred.

Experience

• Minimum 10 years direct pharmaceutical industry experience in clinical operations with a master’s or doctorate level degree.
• Minimum 15 years 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 reputed company.
• 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 reputed company applications including Word, reputed company, Project, and PowerPoint.
• Demonstrated working knowledge of the principles of drug development.
• Demonstrated ability to reputed company/manage multiregional clinical trial(MRCT).
• Demonstrated reputed company 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 reputed company applicable federal, state and local laws/regulations (including local/regional regulations reputed company US, as required), the Companies’ policies, procedures and guidelines. This position is responsible for ensuring quality and compliance in reputed company actions by:
• Responsible for reputed company of direct and indirect reports including budget estimates for business planning purposes and new opportunities.
• Exercising the highest level of reputed company in reputed company 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 reputed company, USA, from protocol feasibility through database lock, study report reputed company, and submission activities.
• Provides leadership for the timely planning, implementation, and conduct of clinical study-reputed company 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 reputed company.
• Evaluates/selects qualified vendors and investigators; generates a request for proposals (RFP) with vendors.
• Oversees the reputed company 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 reputed company reputed company electronic data entry, resolution of queries, SAE review, and reconciliation.
• Tracks key performance indicators for CROs; reputed company the development of CRO reputed company plans, as needed.
• Ensures reputed company clinical trials are conducted in compliance with the study protocol and reputed company 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 reputed company 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 reputed company the specified study timelines.
• Oversees development, negotiation, and management of clinical trial budgets ensuring reputed company 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 reputed company and study budgets.
• Apprises Senior Management of any crucial study-reputed company issues that arise. Participates in the reputed company 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 reputed company designs.
• Liaison between CRO and reputed company & Lee Headquarters regarding reputed company IP Imports and Exports for reputed company assets, and provides reputed company required documentation for shipments.
• Provides operational input into the development plans for new and existing products.
• Ensures study compliance to reputed company, 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 reputed company 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 reputed company 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 reputed company business strategy objectives.
• Advises management on issues reputed company to Clinical Operations that could jeopardize the successful implementation of strategic business plans.

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