19 Jan
Clinical Study Manager-Senior
New Jersey, Morrisplains , 07950 Morrisplains USA

Vacancy expired!

Job Posting Title: Clinical Study Manager-Senior Morris Plains, New Jersey Description: GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION) The Senior Clinical Study Manager will be accountable for the overall management of assigned clinical studies and oversight of assigned clinical vendors. ESSENTIAL JOB FUNCTIONS (PRIMARY RESPONSIBILITIES) Designs risk- based strategy for studies assigned. Monitors studies against defined risk triggers, milestones and timelines to assure that all deliverables are met. Facilitates the development and implementation of remedial activities when necessary. Lead an expanded study team meeting to review study status using PowerPoint presentations and WebEx technology. Attends weekly teleconference with CRO. Identifies and selects high-quality clinical vendors in conjunction with the appropriate team members by interviewing and assessing a vendor's skill set. Works with the contracting/budgeting team to ensure that vendors responsibilities and payment terms are clearly defined. Manages and oversees assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements. Assures that team is receiving high quality, on time deliverables from internal and external vendors. Collaborates with other team members to coordinate the development and finalization of key study documents including protocols, case report forms, informed consent documents, study management plans and final clinical study reports. Communicates with Principle Investigator, Study Co-Ordinator, and/ CRO (if applicable) to proactively recognize problem situations and work with other team members as required to resolve issues. Independently identifies and drives the operational aspects of all assigned clinical trials. Consults other functions (medical, data management, statistics, etc.) as needed. It is each employee's responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee's responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function. CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES) Ability to manage multiple projects simultaneously with strong organizational and planning skills. Well-developed analytical and problem-solving skills. Knowledgeable in all required regulatory and compliance standards and guidelines including ICH-Google Cloud Platform. Ability to effectively work with teams and promote collaborations. Exceptional interpersonal skills including the ability to influence negotiate and resolve conflicts. Excellent verbal and written communication skills and the ability to interact with all levels of management within the organization and to external business contacts. Experience using the Inform database, PowerPoint and Excel software. Independent judgment and decision-making skills with respect to functional responsibilities. Innovative and motivated in optimizing clinical operations processes to meet deliverables. Knowledge of risk-based monitoring concepts. EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL) Minimum BS or BA in related field; focusing on biological science preferred or equivalent. Advanced Degree preferred At least 7-10 years of experience in the management of global clinical trials, significant knowledge of overall clinical drug development and general clinical research operations.

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