Job Posting for Clinical Study Manager at Worldwide Clinical Trials
SUMMARY: This position is in San Antonio and will require candidates to report onsite. 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 the 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.
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