Senior Study Manager, Clinical Operations

 Position Summary:       
Organizes and facilitates the overall planning, coordination, tracking and general performance of clinical studies that support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring clinical study quality and consistency of performance, and in conjunction within Clinical Operations and with all other teams/departments is responsible for overall timeline adherence. A critical component of the position is the peer management, support of, and coordination with contract research organization (CRO) personnel, consultants, contractors, and other colleagues to ensure adequate resource volume and quality is maintained on the studies for which the SSM is responsible.Responsibilities and Duties: 

• Assumes overall responsibility for the preparation monitoring and management options, (either in-house or contracted to a CRO), ethics committee approval, development of recruitment strategies to increase patient enrollment, the provision of clinical trial materials and management of the trial contracts with the internal team, CROs and study sites. Participates in the preparation of protocols and Case Report Forms (CRFs), and data management plans.
• Works with CROs to develop electronic systems, establish processes and plans, mitigation strategies, etc. in order to establish a foundation for clinical trials.
• Identifies study specific training with the CROs Project Manager for implementation with Clinical Research Associates (CRAs) and other clinical staff.  Topics include but are not limited to team communication, computer software and IT training, protocol and CRF, adverse event reporting and the importance of pharmacovigilance.
• Responsible for the financial management of the clinical trial in conjunction with his/her supervisor and finance department.
• Establishes procedures to ensure adherence to trial protocols and administrative requirements.
• May be responsible for management of Phase I, II, III, or IV clinical trials with minimal management oversight
• Efficiently maintains and manages the tracking of timeline milestones for all studies as well as overall day-to-day operations of clinical studies.
• Ensures the timely recruitment of trial participants with secure randomization processes, (if applicable) and subsequent efficient and effective data management.
• Monitors the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
• Works to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding, or time.
• Participates on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues.
• Develops systems to track projects including all study, investigator and ethical review board information, patient recruitment activity, and financial management.
• Ensures that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
• Acts as the point of contact for all external and internal functional teams.
• Liaises with the Trials Steering Committee, Data Monitoring, and Ethics Committee as required.
• Provides  regular  and  ad  hoc  information,  both written  and  verbal,  to  all the  trial participants, internal/external teams including reports, updates, guidance, preformed commitments and, possibly, a newsletter.
• If required and when applicable, co-monitors or performs CRA activities.  These responsibilities are inclusive of but not limited to the following:

• Acts as the main line of communication between the sponsor and the investigator.
• Locates and assesses the suitability of facilities at a study center. Verifies that all research staff and facilities have adequate qualifications and resources and these remain adequate throughout.
• Ensures that study centers are set up properly, which includes ensuring each center has the trial materials, investigational products, and training according to trial­ specific industry standards.
• Responsible for the safety and proper conduct throughout the trial.
• Verifies that the investigator follows the approved protocol and all GCP procedures.
• Verifies that source data/documents and other trial records are accurate, complete, and maintained through review of monitoring reports or co-monitoring visits.
• Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs. Verifies that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).
• Communicates deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to internal management and the investigator as applicable.
• Works with internal and external functional teams to ensure all used and unused trial supplies are accounted for.
• Manages the closing down of study centers on completion of the trial.
• Provides support to a clinical team including maintenance of documentation, clinical tracking and information retrieval.
• Prepares and manages clinical documentation and reports.
• Serves as a central contact for communications/correspondence and associated documentation.
• Manages and coordinates internal/external team meetings and internal/external investigator meetings.

• Interacts and communicates with Taiho's partners for both planning and operational execution of day to day activities.
• Prepares PowerPoint slide decks and other presentation materials for a variety of internal and external presentations.

Educational Requirements:   

• Associates degree or equivalent.  Bachelors' degree in in the biological sciences is preferred.

Experience: 

• 3-5 years clinical trial management experience in the pharmaceutical industry preferably with 5+ in Clinical Operations. Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.

Other Skills and Abilities:

• Attention to details and well-organized.
• Ability to work independently with minimal management oversight
• Solution oriented and exceptional collaboration skills.
• Must possess the ability to multi-task and effectively prioritize in order to ensure clinical trial goals.
• Recognize potential obstacles and work to resolve them within set timelines.
• Delivers work conscientiously and precisely even when under pressure
• A team player and able to work in a dynamic environment with attention to high quality results.
• Excellent communication skills both verbal and written.
• Good proofreading skills.
• Takes initiative and utilizes good judgment
• Requires a good understanding of medical terminology
• Knowledge of, and competence in, application of FDA/GCP/ICH guidelines.