Senior Manager, Clinical Trial Management
Position Summary:
The Senior Manager Clinical Trial Management (Sr. MCTM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Trial Managers (CTM, Sr. CTM, Principal Clinical Trial Managers (PCTM) and MCTMs, as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Clinical Trial Management operations.
This position requires the ability to independently lead, manage, and motivate a team of CTMs and Managers (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. The Manager will ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles.
Essential functions of the job include but are not limited to:
Develop, mentor, coach and manage CTMs, PCTMs and MCTMs (if applicable) to progress their skillset as per Precision for Medicine quality standards. Advocate individual growth and career development
Work with the Clinical Operations Management Team and management of other functional areas to continually improve and enhance CTM expectations and procedures to promote quality, consistency and efficiency while achieving established Key Performance Indicators (KPIs)
Provide leadership and oversight on clinical programs. May serve in a managerial capacity in a Clinical Trial Oversight on clinical studies
Collaborate with the Resourcing team to ensure Clinical Operations resource allocations and needs are appropriately met
Generate action plans and provide developmental/strategic oversight to optimize CTM services, with a focus on high quality delivery of individual/team/departmental goals
Provide on-going feedback and development to manage the performance of direct reports.
Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals, and deliverables) to assigned CTMs
Ensure all assigned CTMs have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
Identify quality risks and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
Interact with Project Manager (PM) and/or Director of Project Management (DPM) in the escalation and resolution of clinical study issues, including out of scope activities and resource allocation changes
Ensure CTMs uphold high quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
Develop and revise Clinical Operations SOPs, work instructions, forms, and templates
May develop and review clinical documents such as but not limited to Clinical Monitoring Plan, Reference Manuals, Informed Consent, Site recruitment plans, CRA tracking materials. etc.
May participate in the interview process for new CTMs and provide on-boarding training for new CTMs and MCTMs in conjunction with Human Resources, Learning and Development and other functional areas
Ensure CTMs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
Recognize, exemplify, and adhere to Precision’s values that center on our commitment to quality, our people, clients, and performance
Perform other duties and departmental initiatives as assigned by Leadership
Qualifications:
Minimum Required:
Graduate, postgraduate, 4-year college degree or equivalent experience ideally in a scientific or health related field
10 years of industry experience in clinical research, including clinical operations experience in a pharmaceutical company or CRO, or proven competencies for this position
5 years direct supervisory/line management experience in clinical research, preferably with CTMs or CRAs
Working knowledge of ICH GCP guidelines and the clinical development process
Other Required:
Excellent communication and interpersonal skills to effectively interface with others in a team setting
Excellent organizational skills, attention to detail, and a customer service demeanor
Ability to travel domestically and internationally including overnight stays
Preferred:
Experience in managing clinical aspects of complex and global trials
Experience in management of CTM line managers (Manager level)
Skills:
Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
Competencies
Direct work experience in a global, cross-functional clinical management environment
Proven experience in people management with a high capacity for Emotional Intelligence
Ability to develop, coach and mentor CTM staff and hold personnel accountable to achieve goals and address training needs
Proven experience in risk management and change management
High level of integrity and must inspire and demand the highest standards from assigned CTMs
Exhibits high self-motivation, and the ability to work and plan independently as well as in a team environment
Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
Excellent presentation, verbal, and written communications skills
Demonstrated successful independent negotiation and conflict management strategies
Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and team
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Apply Now
The Senior Manager Clinical Trial Management (Sr. MCTM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Trial Managers (CTM, Sr. CTM, Principal Clinical Trial Managers (PCTM) and MCTMs, as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Clinical Trial Management operations.
This position requires the ability to independently lead, manage, and motivate a team of CTMs and Managers (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. The Manager will ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles.
Essential functions of the job include but are not limited to:
Develop, mentor, coach and manage CTMs, PCTMs and MCTMs (if applicable) to progress their skillset as per Precision for Medicine quality standards. Advocate individual growth and career development
Work with the Clinical Operations Management Team and management of other functional areas to continually improve and enhance CTM expectations and procedures to promote quality, consistency and efficiency while achieving established Key Performance Indicators (KPIs)
Provide leadership and oversight on clinical programs. May serve in a managerial capacity in a Clinical Trial Oversight on clinical studies
Collaborate with the Resourcing team to ensure Clinical Operations resource allocations and needs are appropriately met
Generate action plans and provide developmental/strategic oversight to optimize CTM services, with a focus on high quality delivery of individual/team/departmental goals
Provide on-going feedback and development to manage the performance of direct reports.
Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals, and deliverables) to assigned CTMs
Ensure all assigned CTMs have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
Identify quality risks and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
Interact with Project Manager (PM) and/or Director of Project Management (DPM) in the escalation and resolution of clinical study issues, including out of scope activities and resource allocation changes
Ensure CTMs uphold high quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
Develop and revise Clinical Operations SOPs, work instructions, forms, and templates
May develop and review clinical documents such as but not limited to Clinical Monitoring Plan, Reference Manuals, Informed Consent, Site recruitment plans, CRA tracking materials. etc.
May participate in the interview process for new CTMs and provide on-boarding training for new CTMs and MCTMs in conjunction with Human Resources, Learning and Development and other functional areas
Ensure CTMs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
Recognize, exemplify, and adhere to Precision’s values that center on our commitment to quality, our people, clients, and performance
Perform other duties and departmental initiatives as assigned by Leadership
Qualifications:
Minimum Required:
Graduate, postgraduate, 4-year college degree or equivalent experience ideally in a scientific or health related field
10 years of industry experience in clinical research, including clinical operations experience in a pharmaceutical company or CRO, or proven competencies for this position
5 years direct supervisory/line management experience in clinical research, preferably with CTMs or CRAs
Working knowledge of ICH GCP guidelines and the clinical development process
Other Required:
Excellent communication and interpersonal skills to effectively interface with others in a team setting
Excellent organizational skills, attention to detail, and a customer service demeanor
Ability to travel domestically and internationally including overnight stays
Preferred:
Experience in managing clinical aspects of complex and global trials
Experience in management of CTM line managers (Manager level)
Skills:
Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
Competencies
Direct work experience in a global, cross-functional clinical management environment
Proven experience in people management with a high capacity for Emotional Intelligence
Ability to develop, coach and mentor CTM staff and hold personnel accountable to achieve goals and address training needs
Proven experience in risk management and change management
High level of integrity and must inspire and demand the highest standards from assigned CTMs
Exhibits high self-motivation, and the ability to work and plan independently as well as in a team environment
Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
Excellent presentation, verbal, and written communications skills
Demonstrated successful independent negotiation and conflict management strategies
Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and team
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Apply Now