Clinical Trial Lead

Job Description

Job 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.

Duties and Responsibilities:

• 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 appropriate.
• 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.

Education:

• A Bachelors /degree is required.
  A Bachelor’s or Master’s in in a scientific discipline is preferred.
  RN or BSN degree highly desired, equivalent experience may be accepted.

Experience:

• Experience in GCP inspections/audits is highly desired.
• 10 years pharmaceutical development experience including managing CROs.
• 3 years previous people management experience is required.
• Experience and understanding of ICH, and GCP.

Knowledge, Skills and Abilities:

• 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.
• 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.