Clinical Operations Lead

Integrated Resources, Inc

Cambridge, Massachusetts

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JOB DETAILS

JOB TYPE

Contractor

SKILLS

Best Practices, Budgeting, Channel Strategies, Clinical Research, Clinical Trial, Clinical Trial Management, Communication Skills, Conflict Resolution, Contingency Plans, Continuous Improvement, Contract Research Organization (CRO), Cross-Functional, Drug Development, GCP (Good Clinical Practices), Healthcare Quality, Information Technology & Information Systems, Leadership, Medical Research, Operational Strategy, Operational Support, Operations Management, Operations Planning, Organizational Skills, Outsourcing, Problem Solving Skills, Procedure Development, Process Development, Process Improvement, Program Planning, Project/Program Management, Regulatory Requirements, Rehabilitation Nursing, Risk Analysis, Risk Management, Standard Operating Procedures (SOP), Strategic Planning, Team Lead/Manager, Vendor/Supplier Management

LOCATION

Cambridge, Massachusetts

POSTED

1 day ago

Clinical Operations LeadA Few Words About Us Integrated 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.Skills needed:Must possess program level and program planning experienceAutonomous and self motivatingEarly Phase experience essentialScientific Research Collaboration experience extremely desirablePartners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. Leverage Phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy. Independently oversees one or more trials by establishing the operational strategy and securing excellence in execution through the CRO partner.1. Partners with Medical Research and other functions to:Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plansLeverage appropriate on going data review to identify and mitigate patient, study design, data or study conduct issuesEnsure all operational aspects support end point integrity and data validityHas a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrityLeverages Phase expertise (e.g. Phase I, II, III, IV), therapeutic knowledge, as well as internal and external data to develop protocols and expert operational strategy for one or more clinical studies2. Secures operational excellence and delivery for one or more clinical studies by:Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country LeadOverseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRODriving performance, quality, timelines and relationships through the CRO partnership modelChairs the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issuesPartnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the relevant vendor management member for issue resolution3. Strives for effective, consistent, efficient and compliant processes by:Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management groupSeeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phaseFollows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing modelEmbodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership modelAt least 10 years of clinical research study management experience of which at least 4 years has been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations a plus. Prior CRO or investigator site and/or monitoring experience is a plus. Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development. Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas. Ability to establish operational plans and support the CRO in the execution of the plans. Requires a balance of scientific and operational/project management and team leadership expertise. Must be able to build effective relationships across and up and down the organization. Excellent project management skills, including risk assessment and contingency planning. Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model. Able to partner with other functions and both internal and external stakeholders. Excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.All your information will be kept confidential according to EEO guidelines. I'm interested

About the Company

Integrated Resources, Inc

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