Department: I-ACT for Children

Reports to: Director of Clinical Project Management

FLSA Status: Full Time/Exempt

Location:REMOTE

Job Purpose Summary:  The Clinical Project Manager is responsible for participating in the planning and execution of projects while adhering to budget, scope and timeline requirements and applicable regulations, including FDA, EMA and clinical trial guidelines such as the ones issued by ICH.

Education Requirements:

• A bachelor’s degree in a relevant scientific discipline.
• Knowledge and/or certification on implementation of clinical research related GCP and GCP-ICH desirable.

Work Experience:

• At least 3 years of clinical trial/clinical operations experience with evidence of increasing responsibility within the biotech/pharmaceutical or CRO industry.
• Previous clinical trial monitoring experience desired.

Job Duties and Responsibilities:

• Work closely with Director of Clinical Project Management to prepare and manage proposals, follow up and manage projects, maintain all relevant parties informed of progress.
• Develop work orders for potential projects with input from the sponsor organizations and appropriate staff.

Assist the Site Network team as needed:

• Manage timelines, budgets, vendors, and deliverables while maintaining quality .

• Communicate with sponsors regarding logistics including CDAs, contract agreements, support materials and training.
• Develop a close relationship with project leads, by supporting the logistical and operational tasks of each project.
• Plan, support and coordinate special projects as required by senior leadership.

• Assist with any company-wide administrative and logistical needs, as needed.
• Other duties and responsibilities may be assigned.

Knowledge/Skill/Abilities:

• Works well independently and in a team-oriented, collaborative environment.
• Ability to work on complex or multiple projects with minimal supervision.
• Thorough knowledge of FDA/ICH and EU regulatory requirements and guidelines.

• Strong oral and written communication skills, including fluency in technical scientific language and writing, and effectively presenting information to management and general staff.
• Proven positive interpersonal skills.
• Ability to actively maintain good professional relationships.
• Good problem-solving, analytical, and organizational skills.
• Self-motivation and the ability to work in a fast-paced environment with top performers.
• Knowledge of basic finance/accounting/budgeting processes.

Supervisory Responsibilities:  None

Travel
Domestic and international travel: only as needed in support for projects, estimated at possibly 10%

Salary & Benefits

Commensurate with experience and aligned with US benchmarked ranges for a research-based non-profit of this size and complexity.

I-ACT is an Equal Opportunity Employer of Minorities/ Women/ Individuals with Disabilities/ Protected Veterans.