Note: The job is a remote job and is open to candidates in USA. UBC is a pharmaceutical support industry leader devoted to empowering health solutions for a better tomorrow. They are seeking an experienced Sr. Clinical Project Research Manager to lead 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 all study related items, with oversight of all aspects of project conduct, from study start-up through close-out in accordance with company and project specific SOPs, guidelines, budgets, timelines and contracts
- Execute operational aspects of assigned project activities as well as special projects
- Assist in the development and design of protocols, CRFs, regulatory documents, project master file, and other project related 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 progress as compared to established plans and ensure compliance with plans
- Facilitate and plan investigator meetings; recruit qualified 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 timely; provide reports to the Sponsor on project progress
- Lead projects with cross functional involvement and supervise all functional areas that support the project
- Assist in revenue and invoicing for project(s)
- Supervise all 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 all inquiries and issue resolution for site management, contract budget and remediation, and regulatory document preparation
- Lead internal client teleconferences and/or meetings and present project information at client meetings, bid defenses and UBC monthly project review meetings
- Maintain project documentation to be 'audit ready'
- Support APM/PMs in sponsor/regulatory audits as required
- Assist in preparation of client 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 form or REMS and REMS Supporting Documents as required
- Initiate and lead process improvement activities
- Accurate reporting and interpretation of project metrics
- Proposal and implementation of action plans
- Satisfactory delivery of contracted services and achievement of contracted milestones for assigned projects
- Duties described for Project Manager and other duties as assigned by management
- Supervision of project management staff in execution of assigned projects
- Prepare PMs to make presentations to clients in defense of proposals
- Ensure that the APM/PM understands the client 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 positive attitude
Skills
- 5 years of experience managing global clinical trials within the CRO industry
- Observational study experience
- BA Degree or minimum 5 years of direct 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 resolution
- Solution driven
- Manage competing priorities effectively
- Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
- 10% travel
- Oncology experience is preferred
Benefits
- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
Company Overview
Company H1B Sponsorship