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Clinical Project Manager III

Integrated Resources, Inc

Lexington, Massachusetts

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Best Practices, Bid Analysis, Biotech and Pharmaceutical, Budget Management, Budgeting, Case Report Form (CRF), Change Requests/Orders, Clinical Data Collection, Clinical Information, Clinical Information Systems, Clinical Monitoring, Clinical Research, Clinical Study Publications, Clinical Trial, Clinical Trial Management, Clinical Validation, Communication Skills, Contingency Plans, Contract Research Organization (CRO), Contract Review, Cross-Functional, Data Quality, Detail Oriented, Documentation Plan, Drug Development, Establish Priorities, Financial Management, Financial Reporting, Forecasting, Healthcare, Information Technology & Information Systems, Mail Processing, Maintain Compliance, Matrix Management, Medical Products, Mentoring, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Monitor Regulations, Multitasking, Organizational Skills, Outsourcing, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Project Management Software, Project Tracking, Regulations, Regulatory Requirements, Rehabilitation Nursing, Request for Proposals (RFP), Research & Development (R&D), Schedule Development, Status Reports, Strategic Planning, Systems Administration/Management, Team Lead/Manager, Time Management, Vendor/Supplier Evaluation, Writing Skills
LOCATION
Lexington, Massachusetts
POSTED
3 days ago
Clinical Project Manager IIITitle: Clinical Project Manager III Location: Lexington, MA, United States Duration: 06+ MonthsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionResponsible for the planning, implementation, execution and management of one or more complex clinical research studies. Manages clinical outsourcing to CROs and other vendors such as IRT, central and specialty labs, etc. May author, review and approve various study related documents and plans. Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required. Leads cross-functional team and is responsible for the financial management of the study (ies).Responsibilities % of Time Job Function and Description 10 %: Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline Authors/contributes to clinical study documents. Reviews and approves study related plans generated by Clinical CROs and vendors Provides input as the subject matter expert for the study during regulatory inspections. 40% Responsible for the clinical review and/or approval of CRFs, completion guidelines and the data review plan Responsible for oversight of identification and selection of investigator sites. Responsible for planning and conducting investigator's meetings. Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team. Collaborates with the cross-functional team on selection and management of clinical vendors. Liaises and coordinates with document specialists regarding study files. Manages escalation of study related issues and communicates as appropriate with management and other R&D functions. Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight. 40 %: Trains and manages CRO and other clinical vendor activities to ensure the quality meets Client and regulatory requirements. Monitors the status of clinical data collection of assigned clinical studies. May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance. Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required. Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact. Responsible for maintaining tracking information in the clinical trial management system, confirming resolution of data quality issues with the CRO. Reviews correspondence and monitoring reports relating to the study. Evaluates CRO and vendor performance for future work. Provides periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Programs Lead (CPL) as requested. 5%: Develops and monitors budget for clinical study, and reviews budgets and contracts with CROs, vendors, and investigative sites (as applicable). Requests and critically evaluates proposals and change orders from CROs and vendors. Leads team through selection process and provides input into contracts, change orders, and/or work orders. 5%: Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities. Supports department initiatives and process improvements. May mentor other Study Managers.QualificationsEducation and Experience Requirements Bachelor's degree is required. Scientific/health care field preferred, but not required. Experience (5+ years) working in clinical research within a pharmaceutical company or CRO or similar organization.Key Skills, Abilities, and Competencies Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point Familiarity with financial budgeting and forecasting or reporting Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines. Ability to work successfully within a cross-functional team and a matrix organization. Excellent written and oral communication skills. Ability to interact with investigators, vendors, and individuals at all levels of the organization. Working knowledge of current global regulatory requirements and guidelines governing clinical research.Complexity and Problem Solving Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints. Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/escalate problems in a timely manner.

About the Company

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Integrated Resources, Inc