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JOB INFORMATION
Position Title:Manager, TMF Operations
Position Location: Canada/US/UK
Position Reports To: Manager, TMF Operations
# of Direct Reports: 1-7
Department/Unit Name: TMF Operations/Monitoring & Site Management
JOB SUMMARY:
This position requires an individual with experience in people management who can effectively lead, inspire, and collaborate well with others. The Manager will manage staff in accordance with Alimentiv’s policies. Responsibilities include planning, assigning, and directing work, assessing performance, guiding professional development, problem-solving, and addressing employee relations issues and resolving problems. The Manager will manage activities within functional area to align with specific client needs and Alimentiv’s objectives and ensure all work activities are performed in compliance with requirements of Good Clinical Practice. Relationships built from knowledge, trust and collaboration are key to the success of the Team Lead as they liaise with leadership and other functional groups daily
AREAS OF RESPONSIBILITY:
Key TMF Activities
Participate in Business Development hand-off meetings upon study awarded and any applicable external sponsor meetings, sharing with team knowledge gained and key take away information.
Advise client(s) on metrics that detail TMF Health against targets to ensure program deliverables are being met.
Train and support new TMF Project Managers.
Serve as subject matter expert (SME) on the management of the TMF to develop and mentor staff; contribute to the development and assist with the implementation of TMF specifications, such as process and system changes.
Participate as a TMF SME during audits and inspections, interact with auditors and inspectors to address queries; support the preparation of appropriate audit and inspection responses.
Conduct periodic TMF reviews for completeness, contemporaneous, and quality to provide recommendations, and guidance to support resolution of TMF findings.
Ensure quality checks are performed as per SOPs and monitor staff progress in resolution of identified TMF discrepancies.
Review fully executed client contracts to identify specific requirements pertaining to the TMF; monitor and evaluate TMF to ensure compliance with agreed upon scope of work.
May participate in the costing of TMF services for potential projects.
Collaborate with other clinical teams and functional leadership to manage project related challenges and to achieve exemplary customer service.
May perform TMF project tasks as appropriate based on resourcing gaps, aggressive timelines, or training.
Team Management and Engagement
Monitor and review performance management of direct reports; conduct regular one-to-one meetings to discuss performance employing coaching and mentoring skills, constructive criticism, and help with goal setting and management through empowerment and motivation techniques.
Provide a positive working environment, with a focus on developing and retaining members in the TMF Operations group.
Ensure every team member knows what is expected of them; what it takes to be successful, and how they are progressing; provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating Alimentiv values; help team members understand how their work contributes to the overall success of Alimentiv by continuously communicating priorities, decisions, and changes, adjusting goals as needed.
Conduct reviews of work performed by staff to ensure quality deliverables including tasks related to performance evaluations, feedback, and development plans.
Identify issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
Create an environment oriented to trust, open communication, and creative thinking.
Develop and implement department onboarding, training, and career development plans using collaboration skills.
Ensure staff has the proper materials, systems access, and training to complete job responsibilities; provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.
Facilitate problem solving and collaboration, intervening when necessary, to aid the team in resolving issues.
Establish and monitor staff KPIs to develop and drive department strategies and goals.
Department Operations
Manage a team of TMF staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives.
Participate in the allocation of resources to studies by assigning staff to studies based on their experience and training.
Support the alignment of activities and objectives of the TMF Operations groups with the organization’s core values, strategy and vision.
Support business development and growth by developing and maintaining process improvements (SOPs, work instructions, TMF plans, etc.), optimizing staff performance and utilization, trending and providing ongoing feedback.
Actively identify continuous improvement opportunities through process and metrics analysis and apply lessons learned across study teams; provide education, feedback, and support to study teams in order to build knowledge and awareness of good document management practices; provide support and guidance to study teams to drive performance against metric targets; analyze error trends in documentation and provide feedback to leadership and functional lines to enable continuous improvement.
Develop and conduct TMF user training (internal and external) and train-the-trainer training sessions.
Involve other functional groups, as applicable, to develop, optimize and maintain TMF guidance documents, tools, and training materials.
Prepare and/or determine standards for the organization’s TMF best practices and lead/participate in TMF process improvement initiatives.
Maintain up-to-date knowledge of the TMF Reference Model, industry best practices and regulatory considerations.
Propose and collaborate on department initiatives and strategies.
Lead team meetings as appropriate.
Support corporate change management initiatives, communication plans and other engagement strategies.
Actively participate in the department hiring process, and onboard training; know what skills, experiences and capabilities are needed to achieve current and future business goals; consciously create a team with diverse backgrounds, experience, skill sets and perspectives; help new team members successfully integrate into Alimentiv so they can actively contribute and add value as quickly as possible.
May represent department on company improvement initiatives, committees, work streams and governances.
May represent the department at business development, sponsor and/or other professional meetings.
Travel domestic and/or international to other office locations and/or for training opportunities.
QUALIFICATIONS:
Applicants should have a minimum of a College Diploma/Degree and 4-6 years of relevant experience. Certificate/Certification in Clinical Trial Management or Clinical Research is preferred. Additionally, candidates should have staffing, planning, and people management experience, with a demonstrated empathetic leadership approach. Ability to adapt to a changing environment, effectively organize and manage multiple priorities and lead team to do the same The successful candidate will possess experience analyzing company needs, employee development and goal setting.
WORKING CONDITIONS:
Occasional travel
Home-based
