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.
SUMMARY: The Senior Project Manager (SPM) will manage one or more allocated Phase I through IV Clinical Trials that may be local, regional or global in scope. Therapeutic experience with Infectious Disease, Respiratory and/or Vaccines and prior CRO experience are required.
- SPM 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 major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, make good business decisions and ensure solutions are implemented.
- Works to ensure that all project deliverables meet the customer’s time/quality/cost expectations
- The SPM, 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.
- Lead core project team 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 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 Worldwide 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 and vendors to ensure client satisfaction and operational excellence.
- Ensure that all staff allocated to assigned projects adheres to professional standards and SOPs established for clinical research.
- Manage all aspects of designated projects
- Perform other duties as assigned by management.
OTHER SKILLS AND ABILITIES:
- The SPM possesses a high level of the following skills and attributes
- Sound knowledge of the key principles of cross functional project management (time, quality, cost)
- Solid financial acumen
- Effective negotiation technique and evidence of commercial and organizational knowledge
- Displays effective communication skills (listening, oral and written) and can communicate in the English language (oral and written)
- The ability to persuade, convince, and influence/impress others
- Organizational skills and proficiency at multi-tasking with good attention to detail
- Demonstrated ability to lead, motivate and coordinate teams and coach/mentor team members as appropriate
- The ability to delegate effectively and prioritise own and workload of project team members
- Cross cultural awareness and ability to adapt appropriately
- Ability to work independently
- 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 seven (7) 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 six (6) years clinical research experience in the pharmaceutical or CRO industries will be considered
- Thorough knowledge of project management processes
- Can demonstrate experience of successfully managing and/or leading multidisciplinary project teams
- Experience using project management software
- Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Solid understanding of how to craft and manage a project budget
- Available for domestic and international travel, including overnight stays
- Valid current passport required
- Ability to drive and have a valid driver’s license
- Broad knowledge of drug development process and client needs