Clinical Project Manager

Roles and Responsibilities

• Serves as study lead and primary (internal and external) contact for clinical studies
• Leads and manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, US and Ex US regulatory guidelines and operate within established timelines
• Responsible for managing the study budget and reviewing forecasts, accruals and actuals
• Manages outsourced clinical operations functions, which may include contracted investigational supply, data management biostatistics, etc.
• Generates and presents frequent study status updates and reports to internal team
• Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
• Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones
• Provides study updates accurately and regularly through frequent communication
• Pro-actively Identifies issues and develops problem-solving strategies to ensure delivery of quality data
• Ensuring that study Trial Master File is maintained and up to date and manages TMF audits as needed
• Prepares for and participates in third-party audits and regulatory inspections
• Complies with ICH GCP guidelines, FDA regulations, and company SOPs
• Performs additional duties as assigned.

Qualifications:

• Minimum BS/BA from an undergraduate program or equivalent experience
• Minimum of 3 years’ clinical operations/ management experience
• Proven ability to be careful, thorough, and detail-oriented
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• Excellent communication and interpersonal skills with customer service orientation
• Proficient with MS Office Suite, particularly Word and Excel
• Self-starter who thrives in a collaborative team environment
• Flexibility to travel up to 25% of time

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.