CTG STUDY MANAGER in Whippany, New Jersey
Title: STUDY MANAGER
Job Number: 17203130
CTG is seeking a Study Manager to work at their client's site in Whippany, NJ 07981. This is a 1 year contract position with a good possibility of extending longer.
The Study Manager manages and is responsible for all aspects of assignedPhase I and extended Phase I/II a clinical trials, within the approved Clinical Sciences Development Plan (CSDP).
These studies are conducted within the standards set by the client and according to Good Clinical Practices (GCP) and applicable regulatory and legal requirements.
The Study Manager manages all study related activities from approved study concept to the final clinical research report (CSR) and ensures that study execution is on track.
As a member of the Operational Sub-team of the ECT/CST he/she provides input to this team to ensure there is accurate tracking.
Within the framework given by the ECL/CPL and the OPL, the Study Manager develops controls and is accountable for the overall study budget and informs the team on budget issues and/or concerns.
The Study Manager implements, manages and leads a cross functional study team for the entire duration of the study.
The overall objective for the Study Manager is to manage the planning, implementation, analysis and reporting of assigned clinical pharmacology studies within the established timelines and budget, ensuring high quality of study conduct and data obtained as well as all requirements necessary for global regulatory approvals.
The Study Manager is expected to proactively provide and implement ideas and suggestions
• Manages and is responsible for all activities related toclinical pharmacology,complex phase I,extended phase I/IIa 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.
• Occasionally 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
BS degree or equivalent education with 8 plus years of healthcare experience (preferably Pharmaceutical clinical operations experience) of which 2 years working as a study manager in early development clinical operations.
• Solid clinical operations experience as a study manager working in early development managing patient studies or be a research nurse with the following experience: Study coordinator experience onPhase I clinical trialsin a hospital research setting (a General Clinical Research Center, for example); Experience as a Study Manager/Clinical Trial Leader for a pharmaceutical company; Experience as a CRA onPhase I trials
• In depth knowledge of the clinical trial management process including monitoring and study management processes, regulatory requirements, drug safety requirements, data management and statistical processes and budget and financial tracking.
• Proven project/external vendor management skills, including effective planning and organization skills, attention to detail and excellent follow through.
•The position also requires awareness and understanding of cultural differences as well as regional operational differences.
This position is compensated per hour on a W2 hourly basis (no C2C or 1099's).
Apply below or send your resume to Holly Wilson firstname.lastname@example.org. Please reference job 17203130/B-11310 in the subject line.
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG is the most reliable IT services provider, built on 50 years of meeting our commitments to make technology work for clients and deliver real business value. CTG provides industry-specific IT strategy, services, and solutions that address the business needs and staffing challenges of clients in high-growth industries, including major technology companies, large corporations, and government entities located in North America and Western Europe.
CTG's greatest asset is its people, and as such we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work Company by Modern Healthcare (since 2013) in North America, and a Best Places to Work Company in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Job: Clinical Trials / Clinical Studies