CTG Study Manager in Cambridge, Massachusetts
Cambridge, Massachusetts, United States
Dec 02, 2019Post Date
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Duration:Consulting Position Long Term Ongoing 12 Months
Location:Cambridge, Massachusetts 02142
Job Title: Study Manager
Scope of Position:
The overall objective of the Study Manager (StM) in the Oncology Strategic Business Unit is to manage the planning, conduct, analysis and reporting of assigned global studies and complex local studies within the established timeframes and budget, with the quality and requirements necessary for global regulatory approvals. This specific position will be within the Innovation Group and will focus on Immuno-Oncology portfolio.
Day to Day Responsibilities:
•Identifies, implements, leads and manages a global, cross-functional Study Team for the duration of the study, working with functional line management to identify team members and resolve issues. Leads the yearly goal setting process for the study(ies) in scope in close collaboration with study team and all clinical team members
•Represents the study team as a member of the Global Clinical Team
•Disseminates relevant information to study team in an effective and timely manner
•Chairs study team meetings and investigator meetings, leads organization of investigator meetings, holds vendor kick-off meetings
•Develops in cooperation with respective functions appropriate study related training for study team representatives and site personnel according to GCP and BAG Pharmaceuticals development standards to ensure quality and requirements necessary for global regulatory approvals and marketing needs are met.
•In more complex and/or higher priority studies the StM may work alongside a SrStM assuming a co-study manager role
•Manages all study related activities from an approved study concept to the final Clinical Study Report (CSR) to ensure study is conducted in high quality and within the given timeline and budget.
•Manages the possible changes in project scope, timelines and budget
•Develops and implements patient recruitment and retention strategy in close collaboration with the study team.
•Supports development and implementation of integrated data review plan (IDRP) as well as ongoing data cleaning as defined in the IDRP
•Responsible for set-up, regular filing and completeness of study documentation (TMF)
•Liaises with various functions to ensure seamless study conduct throughout set-up, maintenance and closure and initiates actions to resolve issues.
•Supports during Authority Inspections and internal audits and is responsible to get study conduct related findings solved.
•Provides operational input and insight into the preparation of the study protocol and contributes to other core study documents in close collaboration with the study team
•Develops the comprehensive overview and operational plans for the study such as the Study Plan, Oversight Plan etc.
•Measures study performance using appropriate systems, tools and techniques
•As a team member of the Global Clinical Team (GCT), the StM provides input to the GCT to enable accurate tracking and management of the overall Clinical Development Plan (CDP).
•Establishes study milestones with the study team and ensures accurate tracking and reporting of study metrics such as recruitment projections, patient enrolment, data cleaning progress and overall study progress.
•Oversees forecasting of clinical/non-clinical supplies
•Leads study risk levelling and risk mitigation strategies
•Responsible for developing and tracking the total external study budget and accountable for providing monthly, quarterly and yearly estimates information to the Clinical Team and to Controlling.
•Acts as Responsible Outsourcing Person in outsourced studies and manages the selection and oversight of external suppliers (e.g. CRO, Central Laboratory, Central Reading Center, etc.).
•Defines outsourced tasks and develops contract specifications for external supplier in collaboration with global strategic sourcing manager.
•As part of the Innovation Group, the candidate will leverage his / her experience to evaluate existing processes and consider alternative workflows based upon their prior experience.
Required Experience and Skills:
•Bachelor's degree strongly preferred, would consider candidate without a degree with considerable experience as study manager
•7 years of relevant healthcare experience
•3 years of clinical operations experience in the pharmaceutical industry which includes direct monitoring and clinical trial/study management experience. Oncology experience preferred
•In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Conference on Harmonization-ICH regulations) with a proven track record leading the initiation and completion of clinical studies
•Comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters.
•No third party resumes will be accepted
•Drug testing and/or other employment-related inquiries may be conducted
•All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third party vendors)
•CTG will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws
•Candidates must currently reside in USA or Canada
•CTG is an Equal Employment Opportunity employer
•CTG is an E-Verify Company
To be considered for this opportunity, please apply directly through our website by clicking the link below or email your Word version resume toRachel.Bruso@ctg.com
CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
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 in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace 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 Function: Clinical Trials & Studies
Education Level: Bachelor's Degree (±16 years)
Work Remote: No
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