Senior Project Manager, Clinical Trials

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

Responsible for the successful planning, implementation, and execution of contracted activities.  Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial.  Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by RQM+ and our sponsors. Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.  

• 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
• Reviewing and identifying project study trends and proactively responding to client and respective team members
• Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges
• Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements
• Responsible for change management on all assigned projects
• Responsible for assuring projects assigned are run according to SOPs and WP as refined in the contract
• Responsible for assuring project timelines are met as per contract
• Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead
• Responsible for maintaining 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.
• Provide other project support to Managers, as assigned
• Oversee delegation of support staff activities, as necessary
• Assist in the development and delivery of capability and proposal defence 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.
• Responsible to maintain 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
• This position will have supervisory responsibilities.

• Previous management experience required
• 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
• Very limited physical effort required to perform normal job duties.
• Up to 20% travel may be required including international travel
• Must be able to secure a credit card co-signed by RQM+
• 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.
• Prior experience in electronic data capture preferred.

• Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

• This position does not have supervisory responsibilities.

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

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