Clinical Study 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 3,000 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.

What Clinical Study Manager does at Worldwide

Clinical Study Manager (CSM) will manage one or more allocated Phase I through IV Clinical Trials that may be local, regional or global in scope. Worldwide Clinical Trials (WCT) Clinical Study Managers are 100% accountable for the success of their projects: Clinical Study Manager (CSM) is responsible for the overall coordination and management of clinical trials from start up through close out activities. Directs the technical, financial and operational aspects of the projects to secure the successful completion of clinical trials.

Works with functional area leads to identify and evaluate fundamental project requirements, interpret data on complex issues, is responsible for contingency planning and implementation of rescue strategy where needed and ensure solutions are implemented. The CSM works to ensure that all project deliverables meet the customer’s time/quality/cost expectations. The CSM, with support from the Project Management Directors, working in collaboration with other functional area leads, is accountable for ensuring that all project deliverables meet the customer/contract expectations. The Clinical Study Manager works under the direct supervision and guidance of the Site Director.

What you will do

• Always representing WCT in a professional manner (verbal, written, and in appearance) when interacting with sponsors, volunteers, outside vendors, and fellow employees.
• Lead core project team members and facilitate their ability to lead extended/complete project team
• Lead cross unit coordination both internal and external, inclusive of sub-contractors
• Define and manage project resource needs in conjunction with functional heads and establish contingency plans for key resources
• Ensure successful design, implementation, tracking and revision of project plans for assigned projects
• Promote effective teamwork among project team members; resolve conflicts as needed
• Ensure appropriate communication on project-related matters with the CSM Management
• Meet financial performance targets for the assigned clinical projects
• Ensure project deliverables are met according to both WCT and client expectations
• Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
• Act as key client contact for assigned projects
• Establish excellent working relationships with client project teams to ensure client satisfaction and operational excellence
• Ensure that all staff allocated to assigned projects are trained on the study protocol and all other study related processes, adhere to professional standards and to SOPs as well as current Good Clinical Practice (GCP) and applicable local regulations

What you will bring to the role

• Strong communication skills with excellent customer service
• Tenacity, with the ability to multi-task and adjust to a fast paced, virtual environment and constantly changing schedules

• Detail-oriented mindset
• A focus on creating effective relationships with a positive team player attitude
• Proficiency in MS Outlook, Excel, and Word

Your experience

Required: University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities

Preferred: Minimum of five (5) years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks

Other: In lieu of the above requirements, candidates with > five (5) years supervisory experience in a health care setting and four (4) years clinical research experience in the pharmaceutical or CRO industries will be considered and/or proven ability and demonstration of relevant experience and skills in clinical development .

Thorough knowledge of project management processes. Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Available for domestic and international travel, including overnight stays. Valid current passport required.

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does.Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!