Senior Project Manager

Summary

Join RQM+, a leading MedTech service provider, as a Senior Project Manager. You will be responsible for planning, implementing, and executing contracted activities, ensuring successful project completion and client communication. This role requires managing project teams, building client relationships, and maintaining compliance with GCP and RQM+ procedures. You will also contribute to process improvement and training development. The ideal candidate possesses extensive clinical trial experience, strong project management skills, and a deep understanding of FDA regulations and GCP guidelines. RQM+ offers a rewarding work environment with an industry-leading compensation package and a focus on work-life balance.

Requirements

• Nursing or University degree (US Bachelor Level or equivalent) in a health-related field with at least five (5) years direct clinical trial experience in a CRO or research-related organization with at least two (2) years management experience OR equivalent level of education and experience
• Global project management experience within the medical device, diagnostic, SaMD development industry, with previous CRO experience is ideal
• Previous experience in managing people within a scientific/clinical environment is required
• Demonstrated Clinical Monitoring and/or Data Management experience required
• Demonstrated financial management skills required
• Up to 20% travel may be required including international travel
• Thorough knowledge of clinical research process from pre-clinical through regulatory submission, approval and post-approval
• Strong communication skills (verbal and written) to express complex ideas
• Excellent and demonstrated organizational and interpersonal skills
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Ability to manage multiple priorities within a variety of complex clinical trials
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
• Ability to set baseline targets, track trends and implement mitigation plans
• Understanding of basic data processing functions, including electronic data capture
• Demonstrated problem-solving and financial negotiation skills
• Excellent verbal and written communication and presentation skills required
• Working knowledge of current ICH GCP guidelines
• The ability to work independently, prioritize and work within a matrix team environment is essential
• Working knowledge of Word, Excel, and PowerPoint required

Responsibilities

• Responsible for all activities related to implementation of clinical studies
• Manages projects of full scope regional and global projects. Responsible for project team leadership
• Responsible for building and maintaining positive client relationships
• Ability to negotiate with clients to assure RQM+’s operational processes are maintained; projects and budget are completed within scope
• Reviews and identifies project study trends and proactively responds to client and respective team members
• Develops appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges
• Identifies, defines, and documents training requirements in LMS systems and assures project level compliance with study specific training requirements
• Responsible for change management on all assigned projects
• Ensures projects assigned are run according to SOPs and WP as refined in the contract
• Ensures project timelines are met as per contract
• Identifies processes which need updating and documenting to the direct line manager or divisional lead
• Maintains client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware in conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms
• Provides other project support to Managers, as assigned
• Oversees delegation of support staff activities, as necessary
• Assists in the development and delivery of capability and proposal defense presentations to prospective clients
• Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate
• Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually
• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research
• Maintains personal currency documentation for RQM+ SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at every instance of out of office

Preferred Qualifications

Prior experience in electronic data capture preferred

Benefits

• Industry leading compensation package
• Focus on work life balance