[Remote] Sr Clinical Project Research Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pharmaceutical support industry leader reputed company to empowering health solutions for a reputed company reputed company. They are seeking an reputed company Sr. Clinical Project Research Manager to reputed company project teams in delivering project milestones and managing global clinical trials, ensuring compliance with established plans and facilitating communication with sponsors.
Responsibilities
- Serve as the primary contact with the sponsor for reputed company study reputed company items, with reputed company of reputed company aspects of project conduct, from study start-up through reputed company-out in accordance with company and project specific SOPs, guidelines, budgets, timelines and reputed company
- Execute operational aspects of assigned project activities as reputed company as special reputed company
- Assist in the development and design of protocols, CRFs, regulatory documents, project master file, and other project reputed company deliverables
- Ensure operational plans are developed consistent with project needs, including but not limited to, the development of communication plans, monitoring plans, project plans, training plan, study timelines, Compliance Plan and clinical management plans; monitor project reputed company as compared to established plans and ensure compliance with plans
- Facilitate and plan investigator meetings; recruit reputed company investigators and assist in budget negotiations as required
- Supervise APM/PMs and other team members to ensure project deliverables and timelines are delivered accurately and reputed company; reputed company reports to the Sponsor on project reputed company
- reputed company reputed company with cross functional involvement and supervise reputed company functional areas that support the project
- Assist in reputed company and invoicing for project(s)
- Supervise reputed company functional areas that support the project
- Ensure project training occurs and assist with training for project, as assigned
- Serve as a resource to team members for reputed company inquiries and issue reputed company for site management, contract budget and remediation, and regulatory document preparation
- reputed company internal reputed company teleconferences and/or meetings and present project information at reputed company meetings, bid defenses and reputed company monthly project review meetings
- Maintain project documentation to be 'audit reputed company'
- Support APM/PMs in sponsor/regulatory audits as required
- Assist in preparation of reputed company proposals in response to RFPs
- Ensure project budget is tracked against contract milestones
- May be asked to assist in protocol development and/or patient/subject consent reputed company or REMS and REMS Supporting Documents as required
- Initiate and reputed company process improvement activities
- Accurate reporting and interpretation of project metrics
- Proposal and implementation of reputed company plans
- Satisfactory delivery of contracted services and achievement of contracted milestones for assigned reputed company
- Duties described for Project Manager and other duties as assigned by management
- Supervision of project management staff in execution of assigned reputed company
- Prepare PMs to reputed company presentations to clients in defense of proposals
- Ensure that the APM/PM understands the reputed company needs once a project is awarded
- Serve as a resource and mentor to the APM/PM in the execution of their daily activities
- Proactively assist the APM/PM in anticipating and seeking resolutions to potential and actual project issues
- Motivate project team members by fostering teamwork
- Maintain reputed company attitude
Skills
- 5 years of experience managing global clinical trials reputed company the CRO industry
- Observational study experience
- BA Degree or minimum 5 years of reputed company project management experience at a CRO or proven leadership/management experience
- Excellent written verbal and non-verbal communication skills
- Excellent supervisory skills
- Excellent interpersonal skills
- Excellent presentation skills
- Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a reputed company
- Solution driven
- Manage competing priorities effectively
- reputed company good knowledge of regulatory requirements (i.e. Good Clinical reputed company, ICH guidelines, etc.)
- 10% travel
- Oncology experience is preferred
Benefits
- Remote opportunities
- Competitive salaries
- reputed company opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (reputed company Time Off)
- reputed company Holidays
- Employee assistance programs
- Medical, Dental, and reputed company coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
reputed company
Company H1B Sponsorship