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Mgr, Process Training

Full Time | Boston | Massachusetts | United States

About the Job

The Process and Training Manager is responsible for driving the creation of an effective and innovative business process in addition to continuous improvement strategy of the infrastructure/processes to ensure simpler, compliant, and faster delivery of data in support of BioPharma, FMI, and Academic Clinical Trials. They are accountable for the development and improvement of FMI study and data management processes and procedures, associated tools, and supporting systems. Process and Training Managers work closely with cross functional colleagues to continuously improve the core processes, are responsible for driving corrective and preventative actions to process deviations, and are considered a process owner for Clinical Operations and Data Management functional procedures. In addition, this role is responsible for the development and delivery of training, including process training, general onboarding, and maintenance of functional training curricula and training records. This role provides project management, communication, and change management support to department initiatives/goals to ensure project requirements and timelines are clearly defined and align with business needs and priorities.


Key Responsibilities

• Function as Global Process Owner and Drive Process Development and Improvement:

·   Function as Global Process Owner for Clinical Operations and Data Management processes and procedures.

·   Streamline and standardize regulated process delivery across BioPharma and Clinical Development trials.

·   Responsible for development and delivery of procedures, associated tools, and training.

·   Ensure that processes are documented in accordance with established document hierarchy and templates.

·   Partner with cross-functional colleagues to continuously drive improvement and innovation across study and data management processes and systems.

·   Identify requirements for supporting systems, tools/templates.

·   Partner with IT to map and address system requirements and ensure that user manuals are updated as required.

·   Establish Key Performance Indicators/Key Quality Indicators and implement required dashboards/reports to monitor the effectiveness of processes and trigger process improvement as required.

·   Establish influential and effective partnerships with stakeholders in Alliance Management, R&D, Technology and Laboratory Operations, and peer partners within Clinical Operations and Data Management.

·   Monitor processes (through performance and quality indicators) and ensure compliance with process in deliverables are being met and documentation retained.

• Lead Process Training within ClinOps/Data Management:

·   Provide expertise, guidance, and training to internal and external stakeholders on department processes with a focus on the integrity of information delivered to the business.

·   Provide training and superuser support to staff on IT systems utilized by ClinOps/Data Management when applicable.

·   Ensure all training conducted within department is appropriately recorded in learning management systems.

·   Maintain role base curricula for ClinOps/Data Management.

·   Establish training strategy and deliver training.

·   Develop and maintain onboarding training material for all new hires.

• Lead CAPA Development for Functional Processes:

·   Assess NCRs/deviations and open CAPAs as they relate and impact BioPharma and Clinical Development studies.

·   Track deviations and non-conformance reports related to non-compliance with functional procedures.

·   Lead CAPA investigations and develop robust action plans with Quality Assurance (QA) and the business to correct and prevent non-compliance.

·   Collaborate with QA in the review of audit and inspection findings to assess process improvements.

• Provide Project Management Support:

·   Provide planning and coordination for goals/initiatives from development to deployment of deliverables.

·   Perform on-going project risk and issues assessments and critical dependencies analysis, communicating with team members and with goal/initiative leader as appropriate.

·   Develop, distribute, and maintain key team documentation to support project.

• Provide Communication and Change Management (CM) Support:

·   Use core communication and CM methodologies to support delivery of internal and external communication efforts.

·   Ensure that communications meet their objectives by establishing and incorporating communications methodologies assessments.

·   Ensure communications and CM timelines are prioritized in alignment with department and stakeholder business needs.



Basic Qualifications

• Bachelor’s Degree or equivalent in scientific field or equivalent combination of education, training, and experience

• 6+ year of process/SOP development and training experience in a professional life sciences environment


Preferred Qualifications

• Masters or Advanced Degree in a business or scientific discipline

• 8+ years experience in pharmaceutical, medical device, or biotechnology industry; understanding of Good Clinical Practice regulations and guidelines

• Knowledge of clinical trial regulatory requirements and how these requirements relate to the drug development process

• Project management, organizational, and planning skills

• Experience in business process management or training management

• Experience, Skills, Knowledge:

·   Experience of change and communication management

·   Process & training management e.g. process mapping, documentation, training systems

·   Proficiency with use of applications and collaborative tools

·   Ability to work in a team/oriented environment and establishing/maintaining effective work relationships with co-workers within and across a matrix organization

·   Detail-oriented with the ability to prioritize, organize, plan and manage multiple tasks efficiently and complete task assignments independently

·   Strong verbal and written interpersonal and communication skills

·   Understanding of HIPAA and importance of privacy of patient data

Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration

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Internal applicants, please use your FMI email address.

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