Sr Clinical Trials Manager

仕事内容

We are seeking a highly motivated individual to join us as a Sr. Clinical Trials Manager, Clinical Operations. You will manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.

Responsibilities include but are not limited to:

• Oversees all operational aspects of assigned clinical trial(s).

• Oversees clinical trial conduct including study start-up, enrollment, study conduct and close-out.

• Prepares and reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters). Provides oversight and guidance if some tasks are delegated to a Clinical Trials Specialist.

• Participates in study strategy development, Line Listing Review, and Clinical Study Report preparation, as appropriate.

• Manages the study project plan, including timelines and budget.

• Provides training and manages CRO vendors such as IVRS, Central lab, Imaging.

• Works with CRO to develop and revise study specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met.

• Further manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files). Creates and implements corrective action plan when performance expectations are not being met.

• Proactively identifies potential study issues/risks and recommends/implements solutions.

• Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. Prepares metrics and updates for management, as assigned.

• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.

• Reviews site study documents (informed consent template and study tools/worksheets).

• Serves as a liaison and resource for investigational sites.

• Participates in the development, review and implementation of departmental SOPs and processes.

• Attends cross-functional meetings as needed to represent Clinical Operations and study-specific issues.

• Provides mentorship and career development to direct reports.

• Other duties as assigned.

KNOWLEDGE:

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Demonstrated analytical and problem-solving skills

• Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.

• Familiar with standard medical / scientific terminology.

• Ability to communicate in a clear and concise manner.

• Ability to support a team-oriented, highly-matrixed environment.

• Ability to execute multiple tasks as assigned.

• When needed, ability to travel.

Required Basic Qualifications

• BS/BA/MS/MA degree in nursing, science or health related field with significant trial management experience

Preferred Qualifications

• A good level of related oncology clinical trial management experience on the sponsor side

• Highly competent knowledge of transplant patient care and apheresis collection a plus

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology

• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management

• Highly developed leadership skills to successfully lead a clinical study team

• Must be willing to travel at least 25% (possibly more)

• Must have previous remote experience to be considered for remote role

• Ability to deal with time demands, incomplete information or unexpected events

• Must display strong analytical and problem solving skills

• Attention to detail

• Outstanding organizational skills with the ability to multi-task and prioritize

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities