Belcan Senior Study Manager in Whippany, New Jersey

Senior Study Manager

Job Number: 280215

Category: Regulatory

Description: A Senior Study Manager job in Whippany, New Jersey is currently available through Belcan. To be considered for this role you will have five years working in early clinical operations in pharmaceuticals including direct monitoring and clinical trial/study management experience and solid clinical operations experience working as a study manager including two years of monitoring experience and a minimum of three years of study management experience. As a Senior Study Manager you will manage and be responsible for all aspects of assigned Phase I and extended Phase I/IIa complex clinical trials, within the approved Clinical Sciences Development Plan (CSDP).

Senior Study Manager Job Duties and Responsibilities:

• Manages and is responsible for all activities related to complex phase I, extended phase I/IIa clinical trials from the approved study concept to the clinical study report and is point of contact for managing/answering questions related to trial procedures and patients eligibility.

• Writes protocols and amendments in collaboration with study team members and is responsible for study specific feasibility and site selection to meet study enrollment and timelines. Responsible for timely delivery of all start up activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight.

• Ensures clinical trial registry and results posting according to global requirements and guidelines, and manages the study insurance according to required timelines and ensures set-up, maintenance and Quality Control of the study Trial Master File (TMF).

• Develops and Leads a Study Team and manages all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings. Develops and manages budget, timelines and quality of the study and its deliverables. Responsible for forecasting and tracking of study costs. Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT) Responsible for training and oversight of CROs to ensure compliance with timelines and budget.

• Together with OPL and ECL/CPL responsible for selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.), developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, ECL/CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues.

• Conducts lesson learned when requested by management or any Study Team member and mandatory at study closure and has to ensure the adequate management of all governance committees involved in the study conduct, i.e. PRC, submission/approval by competent HA and IRBs.

Senior Study Manager Job Requirements and Preferences:

• Bachelor's degree or equivalent education with 8+ years of relevant healthcare experience and five years working in early clinical operations pharmaceutical including direct monitoring and clinical trial/study management experience.

• Solid clinical operations experience working as a study manager including two years of monitoring experience and a minimum of three years of study management experience with in-depth knowledge of study management/project management.

• Comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters with a strong understanding of Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations).

• Demonstrated leadership in project management and vendor management with a strong awareness and understanding of cultural differences as well as regional operational differences. Issue resolution skills are also required.

• There is a 10% travel requirement

If you are interested in this Senior Study Manager job in Whippany, New Jersey please apply via the “apply now” link provided.

Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan engineers better outcomes through adaptive and integrated services—from jet engines, air-frame, and avionics to heavy vehicles, chemical processing, and cyber-security. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.

Location: Whippany , NJ

Minimum Experience (yrs): 8

Required Education: Bachelor (BA, BS...)


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