SUMMARY: The Project Manager (PM) will manage one or more allocated Phase I through IV Clinical Trials that may be local, regional or global in scope. WCT Project Managers are 100% accountable for the success of their projects:
Project Manager (PM) 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 -- thus securing 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.
Works to ensure that all project deliverables meet the customer’s time/quality/cost expectations
The PM, 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.
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
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 PM 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
Job Description – Project Manager
Version Date: 28 JAN 2010 Page 2 of 2
Worldwide Clinical Trials
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
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
Minimum of five (5) years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks
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
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
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
About Worldwide Clinical Trials
Worldwide Clinical Trials is a global CRO providing full-service drug development services to the...