Clinical Trial Lead

Pay Range: $80-$115/hr. Duties:

Summary:

This position will be responsible for supporting and/or leading clinical trials, including overseeing CROs and vendors. Works cross-functionally on operational strategy and related initiatives. Works collaboratively within Development Operations and across cross-functional teams on the study to ensure successful execution of assigned responsibilities.

Assigned Duties may include the following:

• Manages clinical study budget, timelines, and resources, focusing on quality and operational strategies to support study and/or program objectives
• Responsible for developing clinical development operational plans in support for the study
• Oversees execution of studies in compliance with ICH/GCP, local regulations, and Client's SOPs
• Provides input into study budget forecasting and responsible for invoice and budget tracking for individual studies
• Supports the selection, oversight, and management of CROs and other vendors
• In collaboration with the CRO, oversees site feasibility/capability assessments
• Reviews and provide Clinical Operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriat
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
• Represents Client externally to Investigators, site staff, and Key Opinion Leaders
• Represents Client Clinical Operations related to study-specific discussions with collaborators/partners, as applicable
• Performs and documents study level Sponsor Oversight of outsourced clinical activities
• Communicates study-status, cost and issues to ensure timely decision-making by senior management
• Oversees/collaborates on and contributes to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintains oversight of departmental and organizational SOPs metrics for study team to ensure compliance
• Leads and/or participate in the creation and review of departmental and organizational SOPs and initiatives
• Manages the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
• Develops collaborative relationships with key stakeholders; internal and external to Client.
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
• Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Manages internal staffing and performance management, including hiring, training, coaching and performance reviews
• Mentors and develops Clinical Operations staff
• Proposes innovative ideas to help resolve challenges faced by the study team
• Strives for continuous improvement and more efficient ways of working in Clinical Operations
• Acts as a role model for Client's core values

Open to all locations, needs to be available in PST as needed.

Skills:

Requirements:

• Experience in GCP inspections/audits is highly desired
• 10 years pharmaceutical development experience including managing CROs
• 3 years previous people management experience is required
• Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills
• Excellent written and verbal communication skills in addition to excellent project management skills
• Experience and understanding of ICH, and GCP
• Must be a demonstrated self-starter and team player with strong interpersonal skills
• Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint
• Some travel required depending on business needs

Education:

A Bachelors /degree is required; A Bachelor's or Masters in in a scientific discipline is preferred; RN or BSN degree highly desired, equivalent experience may be accepted