Centessa Pharmaceuticals · 20 hours ago

(Sr.) Project Manager – Orexin Research Programs

Boston, MA

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

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Responsibilities

Leads the planning and communication with cross functional teams to ensure proper execution and conduct of the clinical trials

Oversee performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol.. Manage CRO performance to ensure adherence to scope of work within timelines and budget at a task level.

Drive critical clinical trial activities including trial site activations, recruitment, and database lock

Reviews and approves study-related plans generated by CROs, vendors and ensures the documentation are in accordance with GCP, regulatory requirements and consistent with the protocol

Represents and leads the study team to design, develop and deliver the trial to agreed upon timelines

Identify issues and propose solutions; proactively assess potential risks to the study and propose mitigation plans

Drive efficient decision making by acting as a key liaison between the project team and stakeholders while effectively communicating project status and progress to management, partners, and governance teams Provide periodic status reports regarding study timelines, accruals, etc. as requested

Develop and manage critical study documents and plan(s)

Assist study team with preparation for audits/inspections

Maintain project dashboards, Gantt charts, finance systems, and documents to track and report on progress

Manage interdependencies and connections between study-level functions and ensure visibility and alignment;

Facilitate cross-functional study team meetings in preparing agendas, presentation materials, and meeting minutes that ensure follow up of action items

Provide support for the planning and preparation of documents to a quality standard required for Regulatory/Health Authority submissions

Work effectively in a global and virtual environment with an international team, operating across US, EU, and Asia time zones

Provides oversight for the setup, maintenance, and close out of the Trial Master File and ensures it is complete and inspection ready

Qualification

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Clinical Trial ManagementClinical Practices (GCP)ICH guidelinesRegulatory RequirementsProject Management PrinciplesPMP CertificationNeuroscience ExperienceCollaboration Skills

Required

Strong communication, collaboration, interpersonal skills, and influence to accomplish work without formal authority and to ensure optimal team performance.

Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors in a global environment.

Ability to manage multiple priorities with aggressive timelines.

Excellent analytical and organizational skills (resources, timelines, cost/risk/benefit analysis).

Working knowledge of project management principles and practices with the ability to thrive in a fast-paced dynamic environment (PMP certification is an advantage).

Working knowledge of current global regulatory requirements and strong knowledge of ICH guidelines and GCP.

Able to recognize need(s), find solutions and take initiative to address in proactive manner.

Ability to find creative solutions to issues impacting timelines and budget.

Bachelor’s degree (or equivalent) in a relevant scientific field preferred.

8+ years’ experience in the life sciences industry, with 5+ years of Clinical Trial Management industry experience or equivalent academic experience in clinical trials.