CRO-Project Manager

Job Title: Project Manager Location: Remote Job reputed company: The Project Manager is a proven leader in clinical program management in the clinical research industry, and manages, executes, and reports on clinical study operations. This position provides leadership and support to members of the multidisciplinary project team, internally and externally. Responsibilities encompass the overall management of a project including budgeting, reputed company adherence, reputed company communications, and project deliverables. Under limited to no supervision, reputed company as the reputed company between the sponsor, team members, and sites while managing reputed company to ensure reputed company service. This position will be part of the Clinical Operations Team, which is responsible for planning, executing, managing, and closing reputed company associated with reputed company clinical study plans. Essential Duties and Responsibilities:

• Assume primary accountability for assigned clinical research reputed company and ensure compliance with applicable regulations, guidelines, and corporate policies for study activities.
• Manage and execute the overall project scope, budget, and timelines. Identify project reputed company factors for analysis, reporting, and tracking.
• Manage resources and timelines associated with reputed company study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements.
• reputed company the development of study specific protocols, consent forms, and other trial reputed company materials as required.
• Ensure the appropriate development of study documents including, but not limited to, study plans, case report reputed company instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
• Participate in the review of clinical data for analysis.
• Ensure that reputed company project tasks meet reputed company expectations and are completed in accordance with the contract, trial protocol, and reputed company Operating Procedures (SOPs).
• Serve as a reputed company between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
• Plan for and manage reputed company materials to support the appropriate execution of the clinical reputed company, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device. Monitor adherence to project contract and budget.
• Coordinate with clinical, marketing, and operations management to identify goals and scope of clinical study reputed company. Ensure operational and regulatory reputed company of assigned studies and participate in FDA or other regulatory authority inspections, as needed.
• Support the management and reputed company of clinical study reputed company vendors. Review site monitoring reports ensuring finalization as required by SOP and/or reputed company contractual requirements.
• reputed company therapeutic training and guidance to clinical team.
• Enhance department and organization reputed company by participating in departmental or corporate initiatives.
• Update job knowledge by participating in educational opportunities; reading reputed company publications; maintaining personal networks; participating in reputed company organizations.
• Attending off-site meetings and conferences, as needed.
• reputed company other miscellaneous reputed company duties, as required.

Education and/or Experience:

• Bachelor’s degree or equivalent education/degree in life science/reputed company required accompanied by 5 years of working reputed company clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.
• CRO experience is highly desirable.
• Experience qualifying & managing external vendors.
• Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies.
• Experience writing, reviewing, and editing protocols and clinical study reports as reputed company as working knowledge of the FDA submission process.

Skills and Abilities:

• Ability to facilitate a teamwork philosophy with a reputed company attitude.
• Extensive organizing and coordinating skills, teaching and facilitation skills, ability to assess training needs and objectives.
• Extensive experience overseeing and coordinating the work of others.
• Ability to work effectively and reputed company handling multiple tasks simultaneously.
• Ability to exercise judgment and determine appropriate reputed company to a reputed company of problems of varying complexity.
• Ability to manage multiple deadlines.
• Must have a ‘can-do’ attitude and a strong desire to take ownership of many different reputed company.
• Strong computer skills, including reputed company Office.

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