Associate Project Manager, Clinical Trials

*Remote*

Description

The Associate Project Manager would be responsible for managing or supporting multiple Cogstate projects overseeing delivery of cognitive tests and rater training projects. The Associate 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 Associate Project Manager will have demonstrated experience managing or supporting a full workload of clinical projects, and a growing awareness of information technology concepts and terminology. In addition, the Associate 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.

Activities

• Manage projects and execute tasks in line with company SOPs and agreed regulatory standards, including the following tasks:
• Assist PM with Global Phase 1, 2, 3 clinical trials (Cogstate Battery, Scale Tests or Both).
• Lead Phase 1 and 2 studies with limited support from PM supervisor.
• With assistance, manage implementation for projects with new service offerings in scope.
• With support from supervisor, request resources across platform lines and ensure team member follow pre-determined hours allocated in budget.
• With support from supervisor, ability to review Work Orders and determine deliverables and timelines for project.
• Financial Responsibilities - Assess and implement Change Order process and invoice accordingly to contract (including preparation and execution of Change Orders for projects).
• With supervision, analyze reports for project hours and budget utilization in conjunction with PM supervisor.
• Experience in assisting with projects in Start-Up or Conduct or Close-Out phases.
• Proven ability to manage studies in Conduct mode with limited supervision and Start-Up and Close-Out mode with more senior supervision.
• 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.

Requirements

• Bachelor's degree (business, scientific or a technical discipline preferred). Master’s preferred but not mandatory.
• Previous CRO experience preferable.
• 2+ Years Project Management experience in Pharmaceutical, Biotech, or CRO environment.
• Microsoft Office proficiency.
• Budget management experience

Skills, knowledge and Specialist Expertise

• Proven ability to successfully manage a full workload across multiple-projects with supervisory support.
• Able to answer majority of study questions around process, scope, budget with assistance.
• Anticipates problems and develops recommendations for management resolution.
• Highly driven individual who can demonstrate initiative and deliver against tight timelines.
• Growing 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; pro-active 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.

A Cognitive Science Company on a Mission

Our mission at Cogstate is to optimize the measurement of brain health to advance the development of new medicines and to enable earlier clinical insights in healthcare. We are driven by the notion that through our work we impact the health of communities by delivering solutions that combine breakthrough science with advanced technologies. We are inspired by the dedication of researchers and the resilience of patients, and we are strengthened by our 20-year heritage supporting them. We are always working to simplify the complex with solutions that offer insights and hope for the future of healthcare, particularly dementia-related diseases and rare and pediatric disorders

Cogstate Core Values

Do the Right thing

• We are honest and dependable. We keep our promises, act with integrity and foster trust through fairness, transparency, and open communication

Think like a customer

• We see our customers’ challenges as our own and strive to help them succeed. We listen, learn what makes them tick and adapt to creatively meet their needs.

Take care of each other

• We work together to tackle big challenges that can only be achieved through the collective and caring efforts of diverse individuals. We show appreciation, value differences, and celebrate wins.

Lead with science

• We are determined, curious thinkers who use knowledge and data to challenge the status quo and redefine what is possible. We are experts in our fields who are trusted by our customers.

Own it

• We are accountable to excellence and hold ourselves to high standards. We are problem solvers at heart and quick to both identify obstacles and bring solutions

Work hard

• We show resilience in the face of hardship to do the messy work of innovating. We stick to difficult tasks with grit and determination. We iterate, experiment, and embrace failing forward.

See the big picture

• We are driven by an understanding that the work we do matters. Our personal connections to the mission may be different, but we know our “why” and it motivates us to do our best work.

Cogstate is committed to building and maintaining a fair, diverse and inclusive workplace where the personal worth of each employee is recognized, and all are respected and valued for their differences. We believe that having a team of individuals with different backgrounds, skills, experiences, and attributes makes us a stronger organization, including those differences gained on account of gender, gender identity, age, disability, ethnicity, marital or family status, religious beliefs, cultural or socio-economic background or sexual orientation. To learn more, please read our diversity policy here.