Director, Laboratory Services
Location: San Antonio, Texas, United States
Requisition Number: 2546
Position Title: Director, Clinical Services
Summary: The Director of Clinical Services is responsible for the oversight of the Pharmacy, Clinical Lab, PK Lab, Clinical Study Management, and Clinical Data management to support the execution of Phase I studies at Worldwide Clinical Trials Early Phase Services (Worldwide) in-house facilities. The Director of Clinical Services works under the direct supervision and guidance of the SVP, Clinical Operations for Early Phase.
Tasks may include but are not limited to:
- The Director of Clinical Services 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 services to support clinical trial management for Phase I-IIB clinical trials, focusing on the direct events related to the protocols.
- Oversees the management of staff, including PK lab, Clinical Lab, Pharmacy, Clinical Study Management, and Clinical Data Management 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 the 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 monthly.
- Reviews quality reports as appropriate and investigates any action items and ensures remediation.
- Conducts sponsor site visits and tours.
Skills & Abilities:
- Strong interpersonal and communication skills
- Excellent attention to detail and sound judgment
- 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
- Bachelors 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
Employment Type: Regular
Community / Marketing Title: Director, Laboratory Services
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: San Antonio, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.