Clinical Project Manager (Rare Disease, Hematology) - Remote (Canada or US)
Multiple Locations: Canada • United States
Requisition Number: 1863
Position Title: Project Manager
Are you passionate about clinical research focused on improving the quality of life of patients with rare diseases? Worldwide has participated in the design, execution, and/or analysis of >50 studies in orphan diseases. Join our growing team of experts in rare and orphan diseases where you can make a difference!
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. Worldwide Project Managers are 100% accountable for the success of their projects:
Rare disease project management experience working at a CRO is required. Benign Hematology or Sickle-Cell Disease with phase IV studies would be preferred.
- Project Manager (PM) 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 -- 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
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
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Clinical Project Manager (Rare Disease, Hematology) - Remote (Canada or US)
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: Research Triangle Park, North Carolina 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.