Senior Clinical Trial Manager

Worldwide Clinical Trials•Durham, NC

1d•$112,000 - $222,000•Onsite

About The Position

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

Requirements

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
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

Responsibilities

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.