Sr. Study ManagerApply Now

Category: Clinical Project Management
Location: PrincetonNJ
Salary: TBD

Job Description:

Overview:
Manage either internal and/or externally sourced clinical studies that are either regional or global in scope.
Accountable for the successful execution of clinical studies assigned by the Functional Manager. Successfully manages studies within agreed timelines and budget and in alignment with all the applicable SOPs and regulatory requirements. This position will lead study team meetings as necessary and interfaces with appropriate functions internally and externally. The Study Manager is responsible for the day to day functioning of their assigned studies in all aspects of study conduct.

Responsibilities:
 Ensure compliance with FDA and global health authority regulations and guidelines and internal operating procedures and processes as well as ICH/GCP guidelines.
 Initiate collaborative relationships with external institutions/representatives when required.
 Initiate procurement of external resources, consultants, or equipment when protocol required.
 Develop strategies for efficient study conduct, data collection, subject management and safety monitoring. Coordinate efforts inter-departmentally to accomplish these strategies.
 Independently design, develop and review study related documents including but not limited to: clinical protocols, case report forms, site study manuals and project tools, monitoring plans, tracking tools, informed consent forms, and anything else deemed relevant.
 Assist with the development and review of the clinical components of US and Ex-US regulatory submissions.
 Responsible for tracking study milestones to ensure accurate tracking and reporting of study metrics and timelines.
 Responsible for the day to day functioning of assigned studies in all aspects of study conduct.
 Lead study management team meetings and teleconferences with study vendors and properly manage all study deliverables as appropriate.
 Ensure that the study team operates in a constant state of inspection-readiness. Work with internal quality representatives to ensure quality oversight of assigned trial(s) utilizing available tools.
 Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
 Support clinical operations in preparation and/or attendance at departmental meetings, training and developmental activities as required and directed.
 Assist with creation of departmental SOPs and process documents, as needed.
 Other duties as assigned.


Job Requirements:

Qualifications:
EXPERIENCE:
 Minimum of 6 years of experience in clinical trial management (CRO/Sponsor). Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
 Knowledge of clinical study guidelines including FDA, ICH & GCP- Ideal candidate will have a firm grasp of the clinical trial process.
 Phase 1-3 clinical trial experience required; domestic and global experience required.
 Oncology experience is required; immunotherapy experience a plus.
 Previous clinical monitoring experience strongly preferred
 Thorough knowledge of IRB/EC, HIPAA, and FDA regulations with an awareness of global health authority regulations for the conduct of research.
 Strong collaborative, leadership and communication (written and oral) skills.
 Excellent organizational skills and attention to detail.
 Ability to prioritize competing demands to successfully meet deadlines and project milestones.
 Strong computer/technology skills including MS Excel, PowerPoint, and MS Word.

EDUCATION:
 BA/BS preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
 Advanced degree preferable.

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