Covance has an opening in the Start Up Project Management team. This role will oversee and manage the study start up and maintenance activities of regional / global clinical trials. This role can be carried out remotely and our preferred locations include Australia, Korea and India.
As a Start Up Project Manager you will:
- Lead start-up and maintenance team during study start-up and maintenance phase liaising directly with Project Lead, core team members and the client, as applicable.
- Work with cross functional project team and external teams ensuring effective communication, collaboration and teamwork to achieve study objectives and milestones
- Serve as primary client contact, developing and building strong relationships and contributing to meeting / exceeding client satisfaction expectations
- Manage appropriate project resource and lead the core project team to achieve study objectives and milestones
- Assist in the design, implementation, tracking and revision of project plans for assigned studies
- Identify, assess and mitigate study risks
- Track study progress against financial milestones
- Oversee finalisation and distribution of critical study documents for submission (including translations)
- Support budget negotiation, contract escalations and queries with the local team and the client
- Assist in ensuring country specific laws and regulations as well as internal SOPs and processes are followed on your assigned studies
- Support regulatory authority and client inspections, managing any audit findings to their resolution
- Provide performance feedback of team members to respective supervisors
- Support study proposal and bid defence activity, as required
- Minimum of four to six (4-6) years relevant clinical research experience
- Knowledge of financial control procedures (e.g. costing systems, time reporting)
- knowledge of project management processes, especially regarding study start-up
- Excellent organizational and time management skills
- Working knowledge of ICH-GCP, regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred
- Excellent communication skills, oral and written
- Flexibility to attend global meetings
♦University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
♦ Working knowledge of financial control procedures (e.g. costing systems, time reporting).
♦ Working knowledge of project management processes, especially regarding study start-up.
♦ Working knowledge of time and cost estimate development.
♦ Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
♦ Broad knowledge of drug development process and client needs.
♦Masters or other advanced degree.
♦ PMP certification.
♦ Working knowledge of Covance and the overall structure of the organization.
♦ Working knowledge of Covance sales and business development strategies and procedures.
♦ Working knowledge of Covance SOPs.
♦Six (6) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), preferably including three (3) or more years project management responsibility / leading clinical trials in Study Start-up.
♦ Experience in managing global projects with moderate financial value.
♦ Demonstrated ability to handle multiple competing priorities.
♦ Ability to utilize resources effectively on moderate scope projects.
♦ Financial awareness and ability to actively manage financial tracking systems including moderate projects
♦ 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.
♦ Experience mentoring junior level staff.
♦ Excellent communication, planning and organizational skills.
♦ Ability to work independently.
♦ Ability to negotiate and liaise with clients in a professional manner.
♦ Ability to present to staff at all levels.
♦ Good computer skills with good working knowledge of a range of computer packages.
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