Project Manager

Job Description
Health Decisions is the leading clinical research organization (CRO) in Adaptive Clinical Trials, committed to shortening development timelines and maximizing pipeline value for pharmaceutical, biotech and medical device companies. Through Agile Clinical Development — a strategic three-pronged approach that combines adaptive design, adaptive operations and proprietary technology — Health Decisions delivers real-time performance metrics that enable sponsors to make the most of competitive market opportunities.

We are currently seeking a Sr. Project Manager to lead clinical studies and cross-departmental project teams they will also be accountable for ensuring that projects are completed in accordance with contractual and client expectations.

The Project Manager will be responsible for the following across the company:

Schedules, supervises, and delivers services to clients to fulfill contract in accordance with client needs, FDA regulations, ICH guidelines, and HD SOPs.

Manages project and project timelines through all phases, from start-up through close –out.

Manages all contractual and financial aspects of the project, including finalization of initial task order and subsequent amendments, monthly budget reviews, forecasting, assessment of work performed and appropriate client invoicing and site/vendor payments

Ensures that projects are conducted on time, within budget, and meets client agreed upon quality and expectations

Develops and implements the project plan in accordance with the contract and clinical protocol. Ensures cross functional team adherence to these guidelines

Oversees and reviews the deliverables produced by project team members

Ensures cross-functional project team adheres to contract, scope of work, and project plan

Provides overall guidance, motivation and mentoring to project team members including training plans as appropriate

Appropriately delegates to team members, including Clinical Trial Lead (CTL), Clinical Research Associate (CRA) and In-house CRA levels

Creates and maintains quality plans consisting of regular review of study, site and staff
performance metrics.

Assesses and communicates resourcing needs effectively

Manages the client relationship to assure client satisfaction

Serves as the primary project contact for communication and coordination of client, third-party vendor and project needs

Escalates client and team issues to senior management as appropriate

May create, edit or contribute to Clinical Study Reports, protocols, manuscripts and other publications

Acts as a contributing member of department

Assists business development department, as needed, in development of proposals, attendance at sales meetings, trade shows and bid defenses

Additional Responsibilities of Senior PM:

Oversees and mentors junior level PMs on larger projects

Serves as primary relationship manager and/or escalation contact with client for larger projects or suite of projects

Assumes clinical lead responsibilities for applicable proposals and leads strategy and presentation development for bid defense meetings

Leads departmental initiatives as appropriate, including process development and improvement

Qualifications include:

BS/BA degree required; BS/BA degree in scientific or health-related field preferred; or its international equivalent

Progressive experience in the management and conduct of clinical research including ICH-GCP requirements, drug development process, budgeting and forecasting, regulatory compliance, project management, planning and scheduling, leading project teams in a matrix environment, etc.

Strong computer skills, including a solid understanding of Microsoft Office Suite. Ability to learn other applications

Experience supervising or managing professional staff in a clinical research environment

Demonstrated negotiation skills and ability to gain the cooperation of others

Excellent written, verbal communication and presentation skills

Working knowledge of medical terminology, FDA regulations and ICH guidelines

Company

Health Decisions

Job Code

State or Province

North Carolina

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