Senior Clinical Study Manager

Integrated Resources, Inc

Woodcliff Lake, New Jersey

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Analysis Skills, Biology, Biotech and Pharmaceutical, Budgeting, Clinical Monitoring, Clinical Research, Clinical Trial, Clinical Trial Management, Contract Research Organization (CRO), Data Quality, Drug Development, Financial Management, Financial Services, GCP (Good Clinical Practices), Healthcare, Healthcare Quality, Identify Issues, Information Technology & Information Systems, Informed Consent, Leadership, Metrics, Multitasking, Nursing, Operations Research, Organizational Skills, Problem Solving Skills, Project Development, Project Planning, Project/Program Coordination, Project/Program Management, Publications, Regulatory Compliance, Regulatory Requirements, Rehabilitation Nursing, Startup, Status Reports, Team Player, Teleconferencing, Time Management

LOCATION

Woodcliff Lake, New Jersey

POSTED

1 day ago

Senior Clinical Study ManagerIntegrated 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 DescriptionProvide operational leadership for assigned trials executing them on time and within budgetOverall coordination and management of clinical trials from startup to closeoutLiaise with other functional areas to identify issues, evaluate and make sound business decisions and ensure implementation of timely solutions.Identify and select high-quality clinical vendors in conjunction with the appropriate team membersWork with the contracting/budgeting team to ensure that vendor responsibilities and payment terms are clearly defined.Manage and effectively provide oversight of assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements.Assure that team is receiving high quality, on time deliverables from internal and external vendors.Collaborate with other team members to coordinate the development and finalization of key study documents including protocols, case reports forms, informed consent documents, study management plans and final clinical study reports.Work with finance manager on financial aspects of the project(s), including milestone payments, and monthly pass through invoicesLead or facilitate teleconferences with internal or external group.Oversee Clinical Trial Coordinator for assigned project to ensure successful management of project(s), including development of the project plan, maintenance of trackers, and generation of metrics reportsAssume co-monitoring responsibilities as needed.Communicate with Principle Investigator, Study Co-Coordinator, and/ CRO (if applicable) to proactively recognize problem situations and work with other team members as required to resolve issuesManage the publication process in conjunction with the publications team to assure that submission timelines are met.Monitor and report clinical trial status using standard and adhoc review & reporting procedures and identify issues that affect functions. Ensure that each function is accountable for their deliverables.In collaboration with Project Management and utilizing various tracking mechanisms, manage clinical trial project milestones and budget. Proactively identify issues and escalate to appropriate managers.QualificationsMinimum BS or BA in related field; focusing on biological science or nursing preferred or equivalent. Advanced Degree preferredAt least 10 years of experience in the management of clinical trials, significant knowledge of overall clinical drug development and general clinical research operations in Big Pharma.Ability to manage multiple projects simultaneously with strong organizational and planning skills.Well-developed analytical and problem solving skills. Communicates issues to Director with action plans for resolution.Knowledgeable in all required regulatory and compliance standards and guidelines including ICH-GCP.Additional InformationFeel free to forward my email to your friends/colleagues who might be available. We do offer a referral bonus!!Thank you for your time and for consideration. I look forward to hearing from youThanks!!Regards,Jasmine JogewarSr. Clinical RecruiterIntegrated Resources, Inc.IT Life Sciences Allied Healthcare CROCertified MBE | GSA - Schedule 66 I GSA - Schedule 621I732-844-8720| 732-549-5549

Senior Clinical Study Manager

Integrated Resources, Inc

Woodcliff Lake, New Jersey

About the Company

Integrated Resources, Inc

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