Clinical Trial Manager Associate
Assists with all aspects of the design, planning, and implementation of clinical research projects. Participates in and coordinates the protocol and final clinical study report writing efforts. Assist with the conduct of pre-study, initiation, and interim clinical study monitoring visits. Coordinates activities of clinical studies to ensure compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. May travel to coordinate clinical study activities. May assist in drafting clinical study protocols and study documents. May lead the execution of specific clinical study deliverables with the support of the Clinical Trial Lead. Provides updates to the clinical study team as appropriate. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of clinical trials. Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems clinical operations. Prioritizes multiple tasks, plan proactively, and accomplish goals using well-defined instructions. Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional groups.
Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Coordinates study-related activities both internally and externally. Provides support to the Clinical Trial Lead with study-related tasks to ensure efficient execution of clinical trials. Liaise with contract organizations, vendors and other suppliers of project support services to ensure study deliverables are met. Assists with pre-study, initiation, interim monitoring and close-out of a clinical study including monitoring oversight. Assists with site communication and problem solving. Collaborates with Documentation Specialist to set up and maintain the Trial Master File (TMF) and oversees the quality review. to ensure it is complete, accurate and up to date throughout the life cycle of the clinical study and assists with archival of the TMF when the study is complete. Assists with the review and distribution and control of clinical, regulatory and study-related documents (e.g., protocols, informed consents). Under supervision, manages CRO, central labs or specialty vendors. Can review data listings, and may oversee data cuts to meet deliverables, such as interim analysis or for an abstract. Helps to ensure compliance with regulatory and Good Clinical Practices (GCP) requirements prior to shipment of clinical supplies. Assists with ordering and the maintenance of clinical supplies for sites and the study team. May assist with tracking distribution of clinical supplies to site or third party packager. Assists with the design of Case Report Forms (CRFs). May review informed consents. Assists with the coordination and meeting logistics for clinical advisory, consultant or expert meetings, and study-related internal and external meetings. Provides input on agendas. May support and mentor new staff orienting to the CPA role. May maintain meeting minutes, create materials and liaise with meeting planners. May involve 10-20 % travel as required to support clinical studies. Can manage multiple vendors and provide oversight. Assist with the setting and updating of study timelines. Works on project objectives to meet timelines and deliverables. May assist with the budget planning system and assist the clinical trial lead to organize and lead review/approval meetings for CO proposal to track specific and defined clinical projects goals and deliverables. Anticipates obstacles and proactively develop solutions to achieve project goals. Other duties as assigned.
A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted. A minimum of 8 years experience in the Pharmaceutical, Medical Products industry, pharmaceutical product development or pharmaceutical formulations development is required. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. Knowledge of FDA regulatory, ICH, and GCP requirements is required. Must be willing to work as part of a team. Must have demonstrated good interpersonal skills. Good computer skills are required. Working knowledge of MS word, Excel, Power point, and Microsoft office is required.