CSM-Clinical Study Manager
Location: San Antonio, Texas, United States
Requisition Number: 1055
Position Title: Clinical Study Manager
SUMMARY: The Clinical Study Manager (CSM) will manage eight to ten (8-10) Phase I Clinical Trials that may be local, or regional in scope. Clinical Study Manager (CSM) is responsible for the overall coordination and management of clinical trials from start-up through closeout activities. Directs the technical, financial, and operational aspects of the projects to secure the successful completion of clinical trials.
Tasks may include but are not limited to:
- 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
- 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.
- 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.
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 machines, and answering machines.
Required: University/college degree (life science preferred) and a minimum of 3+ years of clinical research experience in a phase 1 unit or similar clinical setting
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.
Employment Type: Regular
Community / Marketing Title: CSM-Clinical Study Manager
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.