Purpose:

The Clinical Research Manager will participate in the planning, development, execution, and maintenance of clinical trials to evaluate the safety, effectiveness, and performance of Tiger BioSciences’ medical device and tissue products. They are responsible for establishing and managing all aspects of clinical study activities from study start-up through report generation while ensuring compliance with, but not limited to, FDA regulations, state requirements, ISO standards, AATB standards, other applicable laws and regulations, Quality System requirements, and company Standard Operating Procedures (SOPs) governing clinical studies. The person in this role will primarily function as an individual contributor but may provide work instruction and oversight to other clinical team members or vendors, as necessary for project execution.

They have a sense of urgency and commitment to meet highly aggressive timelines and will work closely with cross-functional team members to manage clinical projects through operational planning and logistical management to meet departmental and company objectives.

Duties & Responsibilities:

• Establishes, implements, and manages Tiger BioSciences’ clinical study projects.
• Manages clinical study activities including project planning and clinical study design development; collaboration with CRO and other functional groups to establish and implement strategic and tactical plans that are consistent with study objectives; establishing and monitoring clinical timelines and budgets; and communicating clinical requirements and strategies to CRO and clinical staff team members, when required.
• Provides effective communication to ensure that the clinical team understands and plans for all necessary clinical activities to successfully establish clinical study objectives and support required regulatory submissions.
• Contributes to the development of core clinical documents, including the clinical study protocol, case report forms (CRFs), informed consent forms, clinical study agreements, and all other documentation necessary for study initiation.
• Prepares and submits required documentation to Institutional Review Boards (IRBs) for approval. Ensures maintenance of approval throughout the duration of the study and ensures compliance to IRB reporting requirements and with national and international regulations.
•  Provides appropriate training to clinical investigators and staff regarding data collection and reporting requirements, as necessary.
• Ensures clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations, IRB requirements, and Company policies and procedures.
• Supports data management activities, including development and implementation of electronic data capture (EDC) systems to ensure the proper recording, collection, verification, validation, processing, analysis, and storage of information collected in a clinical study.
• Ensures all necessary documentation, including contract agreements are executed, signed, and archived.
• Provides status reports in compliance with federal reporting requirements to regulatory agencies, IRBs, Investigators, and senior management.
• Develops and/or updates clinical-specific procedures to ensure continued compliance with changing domestic and international regulatory requirements and to align with corporate policies/procedures.
• Supports Regulatory Affairs with regulatory filings/registrations when necessary, such as but not limited to development of annual progress reports (APRs), development of clinical study reports (CSRs) for 510(k)s/De Novos/PMAs, clinical expertise related to FDA submission questions, literature reviews to strengthen substantial equivalence positions.
• Other duties as assigned.

• Start job duties on time for established shift.
• Complete required hours on assigned work shifts to complete assigned responsibilities and duties.

Skills & Abilities:

• Ability to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. May work on highly visible projects in high-pressure situations.
• Have working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB requirements.
• Possess strong project management competencies and ability to work with high quality, reliability, and attention to detail.
• Strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross-functionally, and with partners.
• Familiarity with medical and anatomical terminology.
• Ability and willingness to travel; < 10%
• Ability to read, analyze and interpret technical procedures or governmental regulations. Ability to write reports or business correspondence.
• Proficiency with desktop applications, including Microsoft Office and Microsoft Project or other project management spreadsheets, as well as experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems. Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
• Ability to secure and maintain a favorable background investigation and clearance.

Supervisory Responsibilities:

This position does not have direct supervisory responsibilities.

Education & Experience:

• Bachelor’s degree in biological science or related field required. Advanced degree preferred.
• A minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non-significant risk abbreviated IDE trials. Prior experience with biological products preferred.
• Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments.