Clinical Trial Manager II (REMOTE)
Actalent3.4
Charlotte, NC
Job description
Equivalent Experience

Position Summary:
Assist the CPLs for the planning, implementation, execution and compliance of operational plans for clinical study/program with multiple clinical vendors in order to maintain inspection readiness.
This is a tactical position and involves protocol execution at the site level via established vendor oversight and escalation pathways.
Serve as a peer mentor for staff, as needed.
Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted.
Depending on the program scope, the CTM II may have study level responsibilities similar to any other CTM.

Job Responsibilities:
Customize/update any study-specific plans and process flows for multiple clinical vendors, as appropriate e.g., TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release plan etc.
Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted.
Assist CPL by tracking compliance to all study level plans and escalating any variances.
Serve as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF).
Ensure CRA compliance with the study parameters via review of monitoring visit reports.
Track escalation and closure of action items noted in the monitoring visit reports.
Ensure registration of a protocol in ClinTrials.gov/EUdract and monitor its update throughout a study’s life cycle for compliance with the regulations and SOP.
Act as central point of contact for vendor providing this service.
Assist CPL with Interactions with CRO and site staff to adhere to study budgets.
Requests accruals, and performs contract and invoice review.
Participate in operation meetings with CRO, and cross-functional team members; document escalations and actions.
Coordinate study team training in the investigator portal; monitor site/CRA user access and track compliance during the study.
Coordinate with CPL and cross-functional team to assemble study documents as appendices for CSR at study close-out.
Upon site closure, prepares subject files, inventories documents, reconciles document discrepancies, and organizes study files for electronic archive and off-site storage.
SME for initiatives in conjunction with the CoE, as required to ensure consistent implementation of best practices across all studies and within a franchise.

Additional Skills & Qualifications:
>3 years of clinical research experience, in the pharmaceutical industry with a solid understanding of technology and processes used in drug development.
Work with CROs and vendors to drive timelines and deliverables.
Experience working with study budgets and forecasting; contract and invoice review.
Research certification desirable.
Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.

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.
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Company details

Employee

5001 to 10000

Company Description
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’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions. Learn more at actalentservices.com.
Company ratings
  • Overall
    3.4
  • Company & Benefits
    3.3 / 5
  • Culture & Values
    3.4 / 5
  • Career Opportunities
    3.1 / 5
  • Work/Life Balance
    3.4 / 5
  • Senior Management
    3.2 / 5
Company reviews
"Great place to start your recruiting career"
Current EmployeeTechnical Recruiter
This is a great place to start your recruiting career. You'll learn the pace you need to have in order to be successful in your role. Your team will likely be a group of cool people that you like working with and going through the up and downs of recruiting with.

"Actalent Review"
Current EmployeeRecruiter
I love working here, i feel a sense of purpose, have support, and make great money! There is always company outings and a sense of teamwork. Great place to work!
Pros:

"Productive and Encouraging Work Environment."
Current EmployeeTechnical Recruiter
Differentiators between Actalent and other companies are: -Endless opportunities for growth and advancement in your career. -In person & virtual trainings throughout your career. -Flexibility, uncapped potential with commission based role, benefits and total compensation. -Work hard, play hard mentality. -Incentive trips, office/team events, company culture overall. -Impactful and fulfilling work!
Pros:

"Competitive, encouraging, rewarding, and fun workplace"
Current EmployeeRecruiter
Working at Actalent has been challenging and I have grown tremendously in the short time I have been there. The people you work with want you to succeed more than you can believe.