Senior Project Manager- (New Haven Office Or Remote)
New Haven , CT 06510
Posted 4 days ago
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The Senior Project Manager will be responsible for managing multiple Cogstate projects overseeing delivery of computerized cognitive tests and rater training projects. The Senior 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 Senior 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 Senior 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 and execute tasks in line with company SOPs and agreed regulatory standards, including the following:
- Lead Global Phase 1/2/3 clinical trials.
- Independently manage Cogstates most complex computerized cognitive projects and rater training projects - especially around implementation for projects with new service offerings in scope, where process will have to be developed and tweaked as the study progresses.
- May actively line manage and mentor other project management team members and clinical staff. Facilitates team building and communication.
- Independently request resources across platform lines and ensure team members 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.
- Ability to independently analyze reports for project hours and budget utilization and making course corrections in conjunction with Operations Line Managers.
- Directing work of project coordinators and other project managers, including delegating tasks and responsible for QC; providing feedback on performance.
- Work closely with clinical sites to deploy testing materials and train staff.
- 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.
- Subject Matter Expert
- Scales and Rater Training: Act as "go-to" PM for conducting successful complex scales/rater training studies from RFP award to study close-out.
- Technology - recognized throughout Clinical Trials Business Unit as the go-to operational person for support of an application or multiple applications within the Clinical Trials Unit.
- People/Staff management: Demonstrate high performance in mentoring other project management team members and clinical staff to eventually become effective supervisors. Support project assignments.
- Develop operational deployment plans for new systems, including training, and operate as the point person for support.
- Bachelor's degree (business, scientific or a technical discipline (preferred). Masters preferred but not mandatory.
- PMP Certification (preferred but not mandatory).
- Previous CRO experience preferable.
- 7+ Years Project Management experience in Pharmaceutical, Biotech, or CRO environment.
- Supervisory experience (preferred but not mandatory).
- Microsoft Office proficiency.
- Budget management experience.
- Proven ability to successfully manage a full workload across multiple-projects independently.
- Able to answer study questions around process, scope, budget independently.
- Anticipates problems and develops recommendations for management resolution.
- Highly driven individual who demonstrates initiative and deliver on 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 DM and Stats 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.