Sr. Study Manager, Clinical Operations

Taiho Oncology, Inc.•Princeton, NJ

2d•Hybrid

About The Position

Taiho Oncology is seeking a Sr. Study Manager, Clinical Operations to lead and manage complex global studies that support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring assigned clinical studies are delivered within timelines, budget, and quality. A critical component of the position is leading, collaborating with and driving internal cross-functional study teams and managing contract research organization (CRO) personnel and other study vendors. This role performs assigned responsibilities to ensure timely completion of departmental goals and objectives. Taiho Oncology is on a mission to improve the lives of patients with cancer, their families, and caregivers, founded on accountability, collaboration, and trust. They are working on cutting-edge science and growing their portfolio and pipeline across a range of tumor types. The company offers advanced technology, a world-class clinical development organization, and state-of-the-art facilities to empower innovation and touch the lives of more patients.

Requirements

Bachelors’ degree in the biological sciences or equivalent is required.
3-5 years of relevant clinical trial management and leadership experience in the pharmaceutical, biotechnology, CRO and/or healthcare industry.
Demonstrated 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.
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, fast-paced environment with attention to high quality results.
Excellent communication skills both verbal and written.
Good proofreading skills.
Takes initiative and utilizes good judgment.
Knowledge of, and competence in, application of FDA/GCP/ICH guidelines.

Responsibilities

Assume overall responsibility for the planning and execution of one or multiple global trials by managing all aspects of trial deliverables, including development of timelines, budget, recruitment and country/site selection strategies, and provision of clinical trial materials.
Serve as main study contact for the cross functional team, CROs, vendors and study sites.
Monitor KPI and performance metrics and drive related discussions and escalations with the cross functional study teams and CROs/vendors. Escalate risks/issues and reports status to clinical operation lead.
Participate in the preparation of protocols and Case Report Forms (eCRFs), monitoring, communication, and other project plans.
Author and lead the coordination of study specific documents such as Informed Consent.
Work with CROs to develop processes and mitigation strategies for assigned studies.
Collaborate with Clinical Development and CRO on study-specific training for study team and study sites.
Responsible for the financial management of the clinical trial in conjunction with his/her supervisor and finance department, including contracts, change orders and invoices.
Efficiently establish and monitor trial milestones as well as overall day-to-day operations of clinical studies, ensuring study information and timelines are accurate in internal electronic systems, reports and on government websites (CT.gov, etc.).
Ensure the timely recruitment of trial participants with secure randomization processes, if applicable, and subsequent efficient and effective data management.
Ensure compliance with and adherence to the project plan and identify, evaluate and mitigate potential risks and issues.
Oversee systems to track projects including all study, investigator and ethical review board information, patient recruitment activity, and financial management.
Liaise with the Trials Steering Committee, Data Monitoring, and Ethics Committee as required.
Provide regular and ad hoc information, both written and verbal, to all the trial participants, internal/external teams including reports, updates, guidance, preformed commitments, etc.
If required, conduct co-monitoring visits with CROs or CRAs.
Lead site identification and selection process in collaboration with internal medical lead and CROs to ensure suitability of study sites. Verifies that all research staff and facilities have adequate qualifications and resources, and these remain adequate throughout the study.
Ensure that study sites are set up properly and each has the trial materials, investigational products, and training according to trial specific requirements and industry standards.
Verify that the investigator follows the approved protocol, training and all GCP procedures and oversees the quality of the data and safety of the patients. Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to internal management and the investigator, as applicable.
Provide proper oversight of study CROs and vendor activities by creating and managing the CRO oversight plan and related activities, such as review of various monitoring visits report and follows up on any issues or trends, managing risk/issue/decision logs, etc.
Ensure data is entered and monitored in timely manner and that safety is reported in accordance with the protocol on the CRFs.
Work with internal and external functional teams to ensure drug accountability is managed at study sites and that all used and unused trial supplies are accounted for. Ensures IP release process is followed and associated documentation is complete.
Manages sites and study closeout related activities and trial completion.
Overall responsible for the Trial Master File, including review of the TMF plan, related metrics, and ongoing quality review of the TMF. Oversee TMF related CRO and internal team activities to ensure inspection readiness of trial documentation.
Support Quality Assurance on site audits, CAPA and inspection requests.
Manage and coordinate investigator meetings and internal/external team cross functional study meetings and related agenda/minutes.
Interact and communicate with Taiho’s partners for both planning and operational execution of day-to-day activities.
Lead selection, setup and provides oversight to various study vendors such as IRT, ePRO, ECG, Central lab, etc.
Provide support, mentorship, and training for others in Clinical Operations.
Support Clinical Operation department on various projects such as SOP development or process improvement initiatives.