Job Information
Actalent Remote Clinical Trial Manager in Shawnee Mission, Kansas
EXCITING OPPORTUNITY TO JOIN A GLOBAL CRO (FULLY REMOTE)!!
Description:
Responsibilities:
As a Clinical Trial Manager (CTM), you have a wide range of responsibilities. We’re including a few of the big ones. Primarily, you will work to achieve the most successful clinical trial possible. You will lead cross-functional teams with Project Management, Clinical Operations, and Regulatory Affairs, while understanding and managing client expectations. You will proactively identify, resolve/mitigate, and escalate risks or issues when necessary.
Provide Project Oversight and Leadership for Clinical Deliverables
Project Resourcing
Quality – Training & Development
Project Finance
Customer Relations (Internal & External)
Qualifications:
Level 2:
Bachelor’s Degree in a health, life sciences or other relevant field of study, required
8+ years of relevant experience, required
2+ years of experience in clinical trial management, strongly preferred
2+ years monitoring experience, strongly preferred
Experience in managing complex or global trials, preferred
Minimum 1-2 years of experience leading Oncology cellular therapy trials, strongly preferred.
Experience should include oversight of clinical trials using genetically-modified or somatic cell adoptive transfer in either autologous and/or allogeneic settings where cellular product logistics management was used.
Experience in managing all trial components (start-up to database lock), preferred
Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives, preferred
English fluency (ability to read, write, speak), required
Travel of up to a maximum of 10%, required
Level 3:
Bachelor’s degree in a health, life sciences or other relevant field of study, required
10+ years of relevant experience, required
4-5+ years of experience in clinical trial management, strongly preferred
2+ years monitoring experience, strongly preferred
Experience in managing complex or global trials, preferred
Minimum 1-2 years of experience leading Oncology cellular therapy trials, strongly preferred.
Experience should include oversight of clinical trials using genetically-modified or somatic cell adoptive transfer in either autologous and/or allogeneic settings where cellular product logistics management was used.
Experience in managing all trial components (start-up to database lock), preferred
Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives, preferred
Experience in managing complex trials or global trials, preferred
English fluency (ability to read, write, speak), required
Travel of up to a maximum of 10%
Additional Skills & Qualifications:
Ideally have Phase 1-3
2-3 years of experience as a CTM and ideally 1 year of experience as a CRA
Therapeutic experience: Oncology
Location: Open to US
Vendor Management experience is preferred, but not required
Budget/finance experience is required, resourcing focused tasks
Just having trip report oversight will not suffice
Will take regional or global experience
Prefer CRO experience vs. Pharma
Will typically take on 1-2 protocols at a time, depending on # of sites and countries, but sometimes 3 protocols (usually sister studies)
Must have experience developing Clinical Monitoring Plans, Data Cleaning Plans, CRA Data Entry Guidelines, etc.
Experience Level:
Entry Level
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.