Clinical Trial Manager

Description:

 
The Clinical Trial/Operations manager manages study conduct under the guidance of a senior level manager, ensuring that operating procedures and company policies are followed.
 
Develops and manages timelines, resourcing and budget for assigned clinical trials
 
Builds cross-functional support for innovative solutions and mentors/facilitates successful study team behavior. Partners with R&D Managers and Research Scientists/Clinicians to ensure that study deliverables are met.
 
Manages relationships externally with strategic partner monitors, CROs and study site investigators/personnel.



Skills & Qualifications:

 
Medical Device industry experience is required.
 
Knowledge of ophthalmology is Strongly preferred.
 
Experience in Clinical Research in a medical device or pharmaceutical regulated industry. Must have a minimum of 2 years experience as a clinical research associate.
 
Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP).
 
Strong communication, organizational and interpersonal skills.
 
Basic understanding of diverse areas of business (e.g., R&D, Operations, QA, laboratory, regulatory, project management, etc.).
 
Ability to effectively negotiate and influence peers, affiliates and Regulatory agencies (primarily IRBs/Ethics Committees) to ensure that regulatory and business needs are met.
 
ﾠProficiency with MS Word, Excel and PowerPoint is required.
 
ﾠProven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate is required.



Experience Level:
Expert 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.