Senior Manager, Clinical Operations
Our client, a global biotechnology organization are expanding their clinical operations team and are currently recruiting for a Senior Manager to join the team. As a Senior Manager in Clinical Operations, you’ll play an important role in providing clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing.


Responsibilities:

• Facilitates and accelerates the development, execution, completion, and reporting of clinical trial(s) to meet or exceed the clinical development plan (CDP) and within budget and on time
• Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants
• Coordinates and contributes to designing, planning, development, monitoring and reporting of clinical trial(s) in accordance with company (or other applicable) SOPs, ICH E6 GCP, and other regulations and guidance as relevant. Support development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP). Provide oversight of monitoring activities through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs. Provide input into non-project related activities and development of procedures/SOPs
• Primarily responsible for some or all study level deliverables including but not limited to: risk assessment, monitoring plan, study reference/procedure manual, pharmacy manual, template consent, data management plan, statistical analysis plan, safety management plan, etc. Review and refine Clinical Operations Plans/Vendor Oversight Plans
• Ensures that all staff (internal and external) assigned to a study are adequately qualified and trained and that the qualifications and training are documented and submitted to the Trial Master File. Collaborate with cross-functional area heads to ensure proper resourcing for assigned trials. Facilitate training to clinical study teams on protocol specific topics.
• Ensures that the trial master file is prepared, maintained, and catalogued adequately. Ensures the quality control of critical documents. Oversee the submission of trial-related and essential documents to the Trial Master File
• Oversees or personally executes the management of clinical supplies and clinical supply vendors. Develop outsourcing specs for vendor requests for proposal and scope of work agreements. Manage selection of study vendors for assigned studies. Manage the vendor(s) throughout the life of assigned clinical trial
• Manages or ensures the adequate management of other trial related materials and vendors, e.g. ancillary supplies, central laboratories, central IRB, etc. Assist in managing CRO’s/ independent contractors under the direction of the Study Director. Develop outsourcing specs for vendor requests for proposal and scope of work agreements. Manage selection of study vendors for assigned studies. Manage the vendor(s) throughout the life of assigned clinical trial
• Organizes or oversees investigator meetings and other study level meetings. Creates and delivers presentations on study topics as appropriate. Participate in planning and conduct of investigator meetings and ad boards, etc.
• Compile and maintain project specific status reports. Communicates project status to clinical team. Alerts management to risks for subjects, data quality, timelines, budget, and regulatory compliance. Lead ongoing review of data to ensure quality and consistency. Develops and manage program budget(s) and oversees site agreement/budget negotiation process, and manage program timelines. Identify and provide solutions to clinical trial issues or risks
• Provide input on investigational site selection in collaboration with Clinical Development and vendors. Finalizes and approves selection of trial sites and investigators. Ensures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sources
• Participates in departmental planning sessions and clinical policy and process development.Lead/oversee cross-functional CTTs for early phase studies. Define and manage accountabilities for all CTT members
• Is involved with up to 2 clinical products (except in times of personnel transition) and may have up to 3 direct reports including but not limited to, CRAs, Clinical Trial Associates, or other titles relevant to executing clinical trials.
• Mentors, develops, and assesses direct reports including monitoring and managing workload and assignments

• BS degree in related field, scientific background
• 6+ years’ experience in pharmaceutical clinical research. Clinical trial management experience required
• Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations
• Strong analytical skills
• Proficient in Microsoft Office
• Professional, proactive demeanor
• Strong interpersonal skills
• Excellent written and verbal communication skills