Clinical Trials Manager/Sr Clinical Trials Manager

As the overall Senior Clinical trial manager, build and maintain relationships with Clinical team

internally and externally including Coordinators, Investigators, CRAs and CRO team members. Interact frequently with CROs, study vendors and may communicate regularly with senior management. Based on a thorough understanding of conduct of oncology clinical trials, closely monitor all study-related activities from study start-up through study close-out,

Responsibilities and Duties:

• Effective trial management of a clinical study or multiple studies within a clinical

development program.

• Management of the study team for assigned studies or programs and of relationships with

CROs, central labs, IRBs, investigating sites, and other external partners, for one or more

clinical trials.

• Coordinates the activities of all trial conduct partners and team members and proactively

identifies and manages/mitigates risks

• Participate in the development and/or review of all supporting documents for a clinical

study, including but not limited to Protocols, Informed Consent Forms, Investigator

Brochures, Study Manuals, Statistical Analysis Plans, CRFs, Data Management Plans, and

Clinical Study Reports.

• Manage and lead cross-functional clinical trial team meetings collaborating with team

members regarding operational activities pertaining to the execution of one or more

clinical trial(s)

• Identifies, or assists in identifying, investigational sites and participates in reviewing and

approving qualified sites

• Create and review Requests for Proposals, and vendor specifications and participate in the

vendor selection process

• Manages the negotiation of contracts, budgets, and timelines with CROs, vendors, clinical

sites, and other external partners

• Review study invoices and manage accruals for assigned studies monthly
• Participates in the coordination of and training of team members and external partners

(vendors, sites, etc)

• Prepare and maintain assigned study and program files, study documentation, and other

essential documents

• Ensure compliance with internal processes and GCP
• Provide management with routine updates regarding the status of ongoing studies
• May participate in internal/external study-related audits
• Ensure Trial Master File documentation is collected and maintained
• Attend Investigator Meetings and site visits as needed

Requirements:

• At least 5 years of clinical trial management experience; Recent Oncology trial
• Bachelors’ Degree in life sciences or healthcare discipline or equivalent

experience is required.

• Experience with international clinical trials and managing external service providers,
• Working knowledge of GCPc and FDA and ICH regulations and guidelines

including CROs

• Understanding of cross-functional areas including data management / biostatistics,

regulatory affairs, and pharmacovigilance

• Proven verbal and written communication skills; enjoys interacting with others regularly
• Able to prioritize tasks, solve problems and work with a high degree of independence