Senior Manager Clinical Operations

Responsibilities:

Your day-to-day responsibilities will include overseeing clinical trial operations and ensuring compliance with GCP guidelines. You will collaborate with and direct Contract Research Organizations, managing study execution and document development. Additionally, you will oversee data review processes, supervise Clinical Research Associates, and support audits of sites and vendors, ensuring efficient trial management. You will be expected to:

● Lead and supervise all activities related to clinical operations.

● Manage and oversee the conduct and execution of clinical trials and associated activities in compliance with GCP and regulatory requirements.

● Partner with and supervise participating study sites and vendors to ensure efficient and professional conduct of studies.

● Maintain frequent communication with Contract Research Organizations (CROs) to assess performance and provide necessary guidance.

● Manage budget negotiations and expenses to ensure trials stay within budget and utilize resources efficiently.

● Supervise site selection process, identifying and evaluating potential sites and vendors.

● Manage vendors, including clinical and analytical Contract Research Organizations (CROs).

● Lead the development of study documents and tools, including but not limited to, protocols, consent forms, project plans, budgets, and other necessary documents.

● Participate and/or lead in the development of Clinical Operations Standard Operating Procedures (SOP) and training materials.

● Implement and oversee Trial Master File for inspection readiness.

● Lead training sessions for clinical study teams on protocol-specific topics.

● Provide study updates, including risks and issues, to senior leadership.

● Proactively identify project risks and work with necessary teams towards resolution.

● Recommend and implement innovative processes to improve clinical trial management and deliverables, including contingency plans.

● Oversee ongoing data reviews and data cleaning activities.

● Provide oversight of Clinical Research Associates (CRAs) and activities related to site identification, qualification, selection, initiation, monitoring, and close-out activities.

● Support audits of sites and vendors.

● Manage study supplies and ensure compliance with ICH/GCP and global regulatory guidelines.

● Collaborate with other departments to ensure alignment of resources and budgets across programs through evaluation of timelines and task prioritization.

Requirements:

● Bachelor's or Master's degree in a relevant scientific field.

● Minimum of 10 years of clinical trial experience, including clinical trial management and clinical monitoring in pharmaceutical, biotech, or CRO setting: siRNA study experience preferred.

● ICH/GCP Training

● Thorough knowledge of drug development, clinical operation processes, and procedures according to ICH/GCP and other regulatory guidelines.

● Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.

● Proven ability to manage multiple projects simultaneously in a changing environment.

● Strong organizational and time management skills.

● Excellent communication skills, both oral and written.

● Strong team player with demonstrated success in a cross-functional team and fast-moving environment.

● Proven ability to collaborate effectively with internal teams and external collaborators.

● Self-motivated, comfortable working in a start-up environment where everyone contributes to achieving company goals, flexible, and innovative.

● Experience managing Phase I - III trials, knowledge of clinical operations, ICH/GCP, and regulatory requirements.