Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
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 Director of Clinical Operations does
The Director of Clinical Operations is responsible for the oversight of the Clinic, Regulatory Department, Clinical Research Coordinator Department, Data Entry Department, Nutrition Department, and Clinic Scheduling Department to support the execution of Phase I studies at Worldwide Clinical Trials Early Phase Services (Worldwide) in-house facilities. The Director of Clinical Operations works under the direct supervision and guidance of the SVP, Clinical Operations for Early Phase.
What you will do
The Director of Clinical Operations must keep abreast of all changes in study timelines and act accordingly and proactively to resolve any staff training, staff scheduling or procedure issues.
Oversees all clinical operational departments to support clinical trials management for Phase I-IIB clinical trials, focusing on the direct events related to the protocols.
Oversees the management of staff, including Clinic, Regulatory Department, Clinical Research Coordinator Department, Data Entry Department, Nutrition Department and Clinic Scheduling Department and maintains department budgets.
Reviews systems for efficiencies and compliance with regulations.
Partners with Leadership to review studies for feasibility and provide feedback regarding scheduled workload for clinic.
Support Business Development Group when indicated, to promote the capabilities and services of Worldwide Phase I unit.
Assures timelines and the customer's expectations are met.
Reports and actions KPI measures on a monthly basis.
Reviews quality reports as appropriate, investigates any action items and ensures remediation.
Conducts sponsor site visits and tours.
What you will bring to the role
Strong interpersonal and communication skills
Excellent attention to detail and sound judgement
Exceptional organizational and planning skills
Able to project and coordinate Clinic and study needs in advance.
In-depth knowledge of the clinical research process, including Good Clinical Practices and ICH guidelines
Your experience
Bachelor's degree or equivalent year of experience, preferably in the field of Life Sciences or Health
At least 10 years of Clinical Research experience (preferably Phase I)
Minimum 5 years of managerial experience
Strong aptitude for verbal and written communication, presentation, and relationship development
Proven track record of Operational Excellence
Ability to prioritize and respond appropriately to multiple demands.
Possible physical demands include but are not limited to: lifting and carrying of objects weighing 5-50 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.
Why Worldwide
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 www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.