Clinical Trial Manager - Remote

Summary

Flexibility to travel to Massachusetts required

Searching for an independent, collaborative Clinical Trial Manager (CTM) to lead the operations of one of our clinical stage programs. The CTM will lead the implementation of one or more studies and will manage the relationships with our internal study teams as well as close management of external CROs and vendors. This position will report to the Associate Director of Clinical Operations.

Responsibilities

• Oversees and tracks patient recruitment and pro-actively identifies ways to prevent recruitment delays
• Pro-actively i dentifies issues and develops problem-solving strategies to ensure delivery of quality data
• Complies with ICH GCP guidelines, FDA regulations, and company SOPs
• Generates and presents frequent study status updates and reports to internal team
• Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones
• Performs additional duties as assigned
• Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
• Provides study updates accurately and regularly through frequent communication
• 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
• Prepares for and participates in third-party audits and regulatory inspections
• Ensuring that study Trial Master File is maintained and up to date and manages TMF audits as needed
• Serves as study lead and primary (internal and external) contact for clinical studies
• 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.

Qualifications

• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• 1 - 3 years’ clinical operations / management experience from sponsor
• Proficient with MS Office Suite, particularly Word and Excel
• Excellent communication and interpersonal skills with customer service orientation
• Flexibility to travel to Massachusetts
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
• Dermatology experience is a plus
• Minimum BS/BA from an undergraduate program or equivalent experience
• Self-starter who thrives in a collaborative team environment
• Proven ability to be careful, thorough, and detail-oriented
• Experience working with budgets ideal

About Actalent

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.