Actalent Looking for Clinical Trial Manager (REMOTE) at Gaithersburg, Maryland Full Time

Position Overview:

As a major contributor to the successful execution of clinical trials, perform a key role in building and maintaining relationships with Investigators and other study site personnel, CRAs and CRO team members. Based on a thorough understanding of the mechanics of conducting clinical trials, closely supervise all aspects of Clinical Trial Operations, including clinical project management, oversight of study center activities, CRA monitoring activities and vendor management.

Key Responsibilities:

• Directly oversee contract CRAs, CRO study team(s), clinical sites and vendor(s) on assigned studies to ensure consistency of methods, interpretation and approach with other company sponsored studies
• Develop information/consent forms, study training materials, case report forms and study tools for assigned study
• Conduct training for logistics of the clinical trial including protocol contents and coordinating trial materials
• Oversee monitoring activities and conduct clinical site initiation visits, co-monitoring and close-out visits, as needed
• Manage study timeline and provide study progress reports to management
• Plan ahead and provide solution options for handling problems that develop
• Oversee to ensure that paper and electronic filing systems are maintained appropriately and in a timely manner
• Maintain tracking for study metrics essential to managing the study closely (patient visit information, data entry, monitoring and data cleaning information, etc.)
• Ensure that all tasks that contribute to the conduct of a clinical study are completed according to GCPc and SOPs, as well as on time and within budget
• Assist in the development and review of protocols, study budgets, investigator brochures, clinical study reports and other clinical documents and regulatory filings as needed

Additional Skills & Qualifications:

• Bachelors’ Degree in life sciences or healthcare discipline; Master’s Degree preferred
• At least 7 years of clinical trial management experience and at least 2 year of clinical monitoring experience, in the biotech/pharmaceutical industry; experience in supervising people
• Oncology trials experience is required
• Working knowledge of GCPc and FDA and ICH regulations and guidelines
• Experience with international clinical trials and managing external service providers, CROs and contract CRAs
• Good understanding of cross functional areas including data management/biostatistics, regulatory affairs and pharmacovigilance
• Proven verbal and written communication skills; enjoys interacting with others regularly
• Able to prioritize tasks and work independently

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.