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!

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

*RESPONSIBILITIES:*

_Tasks may include but are not limited to:_

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

Oversee regional CTMs and coordinates efforts across the CTM team

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

Contributes 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 assigns sites on behalf of the sponsor

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

Collaborates closely with other functions including Business Development, Regulatory, Study Start up and Project Management to anticipate requirements and achieve study goals

When needed, assumes dual PM/CTM role

Develop, maintain and ensure compliance with Clinical Monitoring Plans, including budgets, study tools and Site visit reports; perform regular review of protocol deviations, Out of Scope items and oversight of action items.

Training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed

Participate in the development of and implementation of recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target

Drive efforts to improve the quality of the site data and deliverables and address any identified needs with action plans. Review data metrics to ensure data integrity and quality

Review of data trends and trip report issues identified for re-training of sites or CRA team. Escalate issues and trends per study expectations.

Oversee TMF compliance of SM documents, ensuring that QC review is on target and TMF is inspection ready

Accountable for Forecasting of site visits w/CRA team to ensure staffing needs are met and any identified backlog is appropriately addressed

Sets performance expectations and provides 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 CTM

Performs Co-monitoring visits where required

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

If needed, Review/finalize trip reports according to WCT SOPs, expectations and as outlined in the annotated report

Supports the study team during inspections by healthcare authorities or sponsor audits

Proactively identifies and mitigates 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

*OTHER SKILLS AND ABILITIES: *

Excellent oral and written communication skills in English

Excellent planning and organizational skills with effective time management

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

Excellent presentation skills

Flexibility to change

Ability to work logically and methodically

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

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

Strong customer focus, ability to interact professionally within a sponsor contact

Strong understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirements

Experience and understanding of therapeutic areas sufficient enough to function as CTM as appropriate

Deep understanding of standard operating procedures

Proficient knowledge of Microsoft Office, eCRF, IVRS packages

Proficiency with IxRS, CTMS and EDC systems

Thorough understanding of clinical research principles and process

*REQUIREMENTS:*

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

Minimum 2 years relevant experience as a CTM/LCRA (or equivalent) including overseeing a CTM team

Travel required

Valid current passport required

Driving 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)*

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 .

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law .