Senior Clinical Trial Manager

Who we are

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.

Why Worldwide

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!

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).

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.

The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):

United States of America - $112,000.00 - $222,000.00 The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .