Clinical Study Manager IN OFFICE SAN ANTONIO
4 days ago
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 Clinical Study Manager
The 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. He/she is not responsible for supervising other staff.
What you will do
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 Liaise with functional line management in identification of any training or development needs and input into the performance appraisal process for trial team members Manage delegated aspects of designated projects
What you will bring to the role
Experience in managing projects in a multi-office environment Demonstrated ability to handle multiple competing priorities; utilize resources effectively Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system Demonstrated ability to lead by example and to encourage team members to seek solutions Excellent communication, planning and organizational skills Self-motivated and excellent problem solving skills Strong interpersonal skills Ability to work independently Ability to negotiate and liaise with clients in a professional manner Good computer skills Must have good customer service skills. Must be able to work effectively with co-workers in a team environment and individually unsupervised. Must be able to perform duties at a fast pace without errors. Must be willing to perform repetitive tasks. Must be able to communicate effectively orally and in writing. Some knowledge and skills in performing technical and laboratory procedures. Experience performing vital signs, ECGs and laboratory procedures. Possible equipment includes, but is not limited to: computers, rolling carts, fax machines, photocopiers, telephone, mop/broom, calculators, postage machine, and answering machines.
Your experience
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.
Other: Ability to drive and have a valid driver’s license
Fluent in local office language and in English, both written and verbal
Broad knowledge of drug development process and client needs Must have flexible hours
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 .
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