Clinical Trial Manager/Senior Clinical Trial Manager

About the Role

Serves as the clinical trial lead responsible for the planning, conduct, and oversight of the operational portion of clinical studies. Ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Responsibilities

• Primary clinical point of contact with the client
• Collaborate with PM on monthly invoicing and variance management of clinical budget
• Develop study-related clinical documents (e.g., clinical plans, Informed Consent Form templates, study-specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides, and other training materials)
• Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol, and practices, including presenting these at Investigator Meetings and Study Kick-off meetings
• Generate potential site list from key stakeholders and drive site feasibility process
• Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
• Develop and finalize the country recruitment/retention strategy
• Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start-up, enrollment, maintenance, and close-out procedures
• Lead internal clinical team meetings and set expectations for the clinical team of CRAs and CTAs
• Address all CRA and site questions and maintain a Frequently Asked Question (FAQ) log as appropriate
• Support in planning and conducting investigator meetings
• Review and/or approve IP release packages
• Oversee, support, and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
• Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
• Generate and utilize metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure the study is conducted per plan and communicate issues to PM and CRAs as appropriate
• Responsible for eTMF implementation and management
• Collaborate with PM, CRAs, and QA to develop any Corrective and Preventative Action Plan (CAPA) and be accountable for implementation and timely closure
• Assist sites, internal staff, and CRAs with the preparation for GCP audits
• Work closely with PM for project-specific resourcing issues
• Escalate pertinent CRA performance and site compliance issues when necessary
• Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
• Manage processes for investigational product (IP) including drug accountability and reconciliation
• When a cross-functional PM is not assigned to a given program, assume project management responsibility as needed
• Support business development and marketing activities as appropriate
• Negotiate site budget and investigator contract with support from the legal department and/or site contracts group
• Review site visit reports and ensure monitoring (i.e., scheduling and scope) is executed per monitoring plan
• Responsible for management of clinical vendors (e.g., labs, IP, patient diary, home health care) in conjunction with PM
• Perform clinical data review of patient profiles, data listings, and summary tables, including query generation
• May have line management responsibilities
• Perform other duties as assigned by management

Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• 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

Skills

• Demonstrates mastery knowledge of ICH-GCP, relevant SOPs, and regulatory guidance, as well as the ability to implement
• Working knowledge of clinical management techniques and tools
• Direct work experience in a cross-functional environment
• Proven experience in functional management, including delegating while fostering cohesive team dynamics
• Proven experience in planning, risk management, and change management
• High level of integrity and ability to inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a team
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results-oriented, accountable, motivated, and flexible
• Excellent time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills
• Excellent presentation, verbal, and written communication skills
• In-depth proven experience in pharmaceutical and/or device research
• Demonstrated successful independent negotiation and conflict management strategies

Pay

Reasonable estimate of the current range: $110,700 USD - $200,900 USD.

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation