Clinical Project Manager
Worldwide Clinical Trials - North Carolina

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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.

RESPONSIBILITIES:
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

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

REQUIREMENTS:
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.

Required Skills

Required Experience

Worldwide Clinical Trials - 17 months ago - save job - block
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About Worldwide Clinical Trials Worldwide Clinical Trials is a global CRO providing full-service drug development services to the...