Sr. Clinical Trial Study Manager - Oncology

Sr. Clinical Trial Study Manager - Oncology

Whippany, NJ

Sr. Study Manager Job description

The incumbent will:

•Manages and is responsible for all activities related to clinical pharmacology, complex phase I, extended phase

I/IIa oncology clinical trials from the approved study concept to the clinical study report.

•Manages all Study Team activities as defined per SOPs/OIs and ensures the organization of

regular Study Team meetings

•Manages the selection and oversight of External Suppliers (e.g. site management and

monitoring CROs, Central Labs, central ECG reading center, etc.)

•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 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.

•Writes protocols and amendments in collaboration with study team members

•Responsible for study specific feasibility and site selection to meet study enrollment and

timelines.

•Together with OPL and ECL/CPL responsible for 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.

•Tracks and compiles patient enrollment, data quality and cleaning progress and overall study

progress and ensures study timelines are met

•Responsible for training and oversight of CROs to ensure compliance with timelines and

budget.

•Develops appropriate study related training for monitors and site personnel according to GCP

and company standards

Qualifications

The qualified candidate is required to possess the following:

•Bachelor’s degree or equivalent education with 8+ years of relevant healthcare experience of which 5 years working in early clinical operations pharmaceutical (preferably oncology) including direct monitoring and clinical trial/study management experience.

Ideal candidate will have solid clinical operations experience working as a study manager including 2 years of monitoring experience and a minimum of 3 years of study management (early oncology) experience is preferred

•The incumbent is responsible for the direct management of Phase I & IIa complex oncology global clinical trials. This requires an in-depth knowledge of study management/project management. In addition Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee-ICH regulations).

The position also requires strong awareness and understanding of cultural differences as well as regional operational differences.

•Demonstrated leadership in project management and vendor management.

•The incumbent requires comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters.

•Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent interpersonal, decision-making and issue resolution skills are required. In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through.

All your information will be kept confidential according to EEO guidelines.