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| Clinical Study Manager TX Open (J#45707) Title: Clinical Study Manager Company: The HTW Group Description ConsignMed, a Niche Clinical Staffing Company since 2003, and rated by Diversity Business as one of the fastest growing companies in the US is seeking a Clinical Study Manager. Responsibilities include leading the development, planning, launch, conduct, closure, and submission and as needed regulatory defense activities of Phase I-IV clinical trials in accordance with all applicable federal, state and local laws/regulations and Company s policies, procedures and guidelines. The Contract Study Manager, Clinical Trial Program Management, will collaborate with the Study Director, Clinical Study Team and Design Control Team (as applicable) on study design. They will take an operational lead on study execution. Responsibilities: Study Development and Management - Collaborate in the operational design and conduct of Phase I-IV US over-the-counter (OTC) clinical studies from protocol feasibility through database lock, study report generation and submission activities - Write protocols and amendments. Coordinate protocol review and approval - Prepare study-specific documents including informed consent documents (ICDs), status update reports, newsletters, training materials. - Participate in review of case report forms (CRFs), CRF completion guidelines, data management plans, statistical analysis plans, inspection readiness plan, and patient-reported outcome scales and questionnaires. - Coordinate the translation of study-specific documents as needed - Manage preparation of Clinical Trial Agreements, Transfer of Obligations, purchase orders, Totality transactions (Healthcare Compliance system), site contracts - Actively participate in the evaluation and selection of qualified external service providers (ESP) (eg, CROs, interactive voice response (IVR) vendors, central laboratory vendors, etc) and investigators; lead the request for information (RFI) and request for proposal (RFP) processes as required. Communicate study specifications to ESPs - Serve as the primary point of contact with ESPs - Monitor progress of studies and performance of ESPs on an continual basis through review of communication and monitoring plans, review of monitoring visit reports, maintenance of study progress via paper and electronic data capture including timely data basing of CRFs, routing/resolution of queries, SAE review and reconciliation - Ensure that all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure patient safety, quality data and accurate study timelines, budgets and quality standards are met - Set-up and maintain Trial Master Files - Manage study timelines including key milestones. Identify and manage critical path activities; anticipate bottlenecks and ensure contingency plans are in place and negotiated with the ESPs to mitigate risk. Help team identify and address system or process issues hindering delivery of high-quality data results within the specified study timelines - Oversee and track subject recruitment and retention. Oversee development of enrollment plan, risk mitigation and site recruitment strategies. Coordinate the review/approval of study-specific recruitment materials - Generate protocol-specific documents required for registry/posting of clinical studies on clinicaltrial.gov. Secure approvals of these documents. Update Protocol Update Requests in Clinical Trial Management System (CTMS) per standard operating procedures (SOPs) - Oversee development, negotiation and management of clinical trial budgets. Track payment schedules against key deliverables - Approve invoices from vendors in order to ensure timely disbursement of payment and compliance with contracts and study budgets - Apprise Senior Management of study-related issues that arise. Participate in the generation of corrective and preventative action plans to address issues - Work collaboratively and cross-functionally (both internal and external to McNeil) with many groups including Biostatistics, Data Management, Clinical Communications, Healthcare Compliance, Project Management, Research & Development, Clinical Supplies, Regulatory Affairs, Safety, Clinical Quality Assurance, Procurement, Innovation Teams, Principal Investigators and their staff, ESP personnel - Contribute to the writing of Clinical Study Reports, Investigator Brochures and regulatory submission documents - Prepare and coordinate Data Safety Monitoring Boards meetings (as needed) - Acquire clinical knowledge of the therapeutic area(s) and compounds under development. Acquire working knowledge of global regulations and guidelines as it pertains to clinical research - Forecasting and coordination of clinical and non-clinical supplies requests, review drug label and kit designs, initiate drug shipment, manage drug accountability, review drug destruction/return policy, including specific requirements pertaining to return of investigational product in Phase I studies Requirements Education: Minimum of a Bachelor of Science degree in Nursing, Pharmacy or scientific field, or equivalent required. Advanced degree preferred Experience: Minimum 8 years direct pharmaceutical industry experience in clinical research operations. Phase I experience required. Knowledge, Skills and Abilities: - Must have well-developed communication skills (both oral and written) and be able to work effectively in cross-functional teams both internally and externally to the organization - Proficient in Microsoft applications including Word, Excel, Project, and PowerPoint - Demonstrated working knowledge of the principles of drug development - Demonstrated ability to manage, one or more large, complex clinical trials - Demonstrated capacity to contribute to study design - Proficiency in GCP and ICH regulations - Efficient, organized and capable of prioritizing multiple tasks - Willingness to adapt to changing priorities and assignments Attention to detail Experience supporting regulatory submissions (preferred) Experience with Vendor Management (preferred) Certifications/Licenses: Nursing/pharmacy license, in accordance with degree, preferred | |||
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