Clinical Study Manager

Requisition Number: 3201

Position Title: Clinical Study Manager

External Description:

SUMMARY: 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.
 
RESPONSIBILITIES:
Tasks may include but are not limited to:

• 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
• 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
• Perform other duties as assigned by management
• 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.

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:

• 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.

 
REQUIREMENTS:
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
 

City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Clinical Study Manager

Company Profile:

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 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 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. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.