Senior Clinical Trial Manager

What the Clinical Trial Manager does at Worldwide

Responsible for overseeing and leading the delivery of clinical study site management activities through the coordination of a team of clinical staff on particularly complex studies, such as those with significant global reach. Responsible for ensuring site qualification, initiation, interim monitoring, site management, and study close-out activities are conducted in accordance with the study protocol and study plan. Uses data metrics and project planning to monitor and ensure the quality of data submitted from study sites and the timely completion of study activities, including appropriate reporting and follow-up for all safety events by site personnel.

What you will do

• Provide leadership and direction to clinical site management team members from study start through closure

• Oversee regional Clinical Trial Managers (CTMs) and coordinate efforts across the CTM team

• Represent Site Management issues at Sponsor, Investigator, and bid defense meetings and act as the main point of contact for activities throughout the study

• Contribute to the overall project plan by formulating a global monitoring strategy for site initiation, enrollment, site management, and closeout phases across a given region and assign sites on behalf of the sponsor

• Provide regular input to various project tracking systems, including project financial performance reports, study metrics and trending, resource allocation to project tasks, time recognition, and other systems as needed

• Collaborate closely with other functions, including Business Development, Regulatory, Study Start-Up, and Project Management, to anticipate requirements and achieve study goals

• When needed, assume a dual Project Manager (PM)/Clinical Trial Manager (CTM) role

• Develop, maintain, and ensure compliance with Clinical Monitoring Plans, including budgets, study tools, and site visit reports; perform regular reviews of protocol deviations, out-of-scope items, and oversight of action items

• Train and manage the Clinical Research Associate (CRA) team on all clinical aspects of the study with support from Project Management, Medical Monitoring, and the Sponsor as needed

• Participate in the development and implementation of recruitment strategies in assigned countries and sites; lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment remains on target

• Drive efforts to improve the quality of site data and deliverables and address identified needs with action plans; review data metrics to ensure data integrity and quality

• Review data trends and trip report issues identified for site or CRA team retraining; escalate issues and trends per study expectations

• Oversee Trial Master File (TMF) compliance of Site Management documents, ensuring quality control reviews are on target and the TMF is inspection-ready

• Accountable for forecasting site visits with the CRA team to ensure staffing needs are met and any identified backlog is appropriately addressed

• Set performance expectations and provide mentoring and coaching to colleagues and project clinical staff when needed, working closely with Clinical Operations Managers on performance feedback; may act as a mentor for CTMs

• Perform co-monitoring visits where required

• May perform site qualification, initiation, interim monitoring, and/or close-out site visits as needed

• If needed, review and finalize trip reports according to Worldwide Clinical Trials standard operating procedures (SOPs), expectations, and as outlined in the annotated report

• Support the study team during inspections by healthcare authorities or sponsor audits

• Proactively identify and mitigate risks

• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Your experience

• Excellent oral and written communication skills in English

• Excellent planning and organizational skills with effective time management

• Excellent interpersonal skills with the ability to work and influence across diverse cultures

• Excellent presentation skills

• Flexibility to adapt to change

• Ability to work logically and methodically

• Ability to lead and motivate assigned team members dispersed remotely across time zones

• Ability to provide experience and input into process initiatives and development related to monitoring and site management activities

• Strong customer focus with the ability to interact professionally with sponsor contacts

• Strong understanding of Food and Drug Administration (FDA) and/or European Union (EU) Directive regulations, International Council for Harmonisation (ICH) Guidelines, and local regulatory requirements

• Experience and understanding of therapeutic areas sufficient to function as a CTM, as appropriate

• Deep understanding of standard operating procedures

• Proficient knowledge of Microsoft Office, electronic Case Report Form (eCRF), and Interactive Voice Response System (IVRS) packages

• Proficiency with Interactive Response Technology (IxRS), Clinical Trial Management System (CTMS), and Electronic Data Capture (EDC) systems

• Thorough understanding of clinical research principles and processes

What you bring to the role

• Four-year college curriculum or equivalent with a major concentration in biological, physical, or health studies and a minimum of four years of experience as a Senior Clinical Research Associate (or equivalent), OR

• Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum of six years of experience as a Senior Clinical Research Associate

• Minimum of 2 years of relevant experience as a CTM/LCRA (or equivalent), including oversight of a CTM team

• Travel required

• Valid current passport required

• Driver’s license required

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Note: The Clinical Trial Manager role may also be referred to as a Lead Clinical Research Associate (LCRA).