Clinical Project Manager
The Project Manager would be responsible for managing multiple Cogstate projects overseeing delivery of cognitive tests and rater training projects. The Project Manager will have a strong interest in the pharmaceutical development process, a special aptitude and interest in technical and scientific information, and be a highly driven individual who demonstrates initiative and delivers against tight timelines. The Project Manager will have demonstrated experience managing a full workload of clinical projects, and a growing awareness of information technology concepts and terminology. In addition, the Project Manager will have confidence and composure in handling stressful situations – communicating calmly and effectively with internal and external stakeholders, particularly in areas of disagreement.
This role will require extensive written and phone interactions between all office locations, as well as with Sponsors and clinical sites in countries all over the world.
Essential Job Functions:
Manage projects and execute tasks in line with company SOPs and agreed regulatory standards, including the following tasks:
- Lead Global Phase 1 and 2 clinical trials (consider North America based Phase 3).
- With support of supervisor, manage Cogstate’s more complex computerized cognitive test projects and less difficult rater training projects.
- With assistance, manage implementation for projects with new service offerings in scope.
- May actively line manage and mentor other project management team members and clinical staff. Facilitate team building and communication.
- With support from supervisor, request resources across platform lines and ensure team member follow pre-determined hours allocated in budget.
- Ability to review Work Orders and determine deliverables and timelines for project.
- Financial Responsibilities
- Manage project to target gross profit consistently
- Assess and implement Change Order process and invoice according to contract.
- With supervision, analyze reports for project hours and budget utilization and making course corrections in conjunction with Operations Line Managers.
- Experience managing projects in Start-Up or Conduct or Close-Out phases (can be over multiple projects).
- Directing work of project coordinators, including delegating tasks and responsible for QC; providing feedback on performance.
- Interact with statistical, science and data management teams internally to identify data quality related issues and risks to clinical activities, develop contingency and mitigation plans to minimize risks, and provide updates and metrics to Sponsor.
- Work closely with clinical sites to deploy testing materials and train staff.
- Attending Investigator Meetings and ensuring Cogstate is well represented.
- Bachelor's degree in a business, scientific or a technical discipline (psychology, nursing, biology, sociology, computer science or engineering preferred). Master’s preferred but not mandatory.
- Previous CRO experience preferable.
- 4+ Years Project Management experience in Pharmaceutical, Biotech, or CRO environment.
- Microsoft Office proficiency.
- Budget management experience.
- Proven ability to successfully manage a full workload across multiple-projects with limited supervisory support.
- Able to answer study questions around process, scope, budget independently.
- Anticipates problems and develops recommendations for management resolution.
- Highly driven individual who can demonstrate initiative and deliver against tight timelines.
- Strong grasp of study deliverables and timelines, with ability to manage competing priorities - ensuring that all deliverables met, on time (or adequate communication is sent); peak periods do not result in other studies being ignored.
- Fully accountable for budget and project plan updates - regular review and updates; proactive communication internally and with Sponsor teams.
- Ability to assess the inherent risks of a situation, their potential impact on a project and based on this information; with limited support make timely decisions.
- Strong understanding around budget amendments, including internal discussions with all relevant departments around new requests.
- Excellent problem solving/decision making skills.
Cogstate is a leading cognitive science company focused on optimizing the measurement of cognition (brain function) to guide decision-making in clinical trials, academic research and healthcare. Cogstate commercializes rapid, reliable and highly sensitive computerised cognitive tests and provides expert support for traditional neurological assessments. Science, innovation and excellence in delivery are at the core of everything we do. Cogstate offers health, dental, and vision benefits as well as 401K plan matching. Cogstate, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or genetics.