Clinical Trial Associate, Study Management
30 Hudson Street Jersey City, NJ 07302 US
Job Description
Target Pay Rate: 30-37.71/hr **salary will be commensurate with experienceÂ
Position Overview:
Under the direction of the Director, Study Management, the Clinical Trial Associate (CTA) Study Management, will be responsible for supporting the Global Clinical Trial Operations department, Study Directors and Study Managers in the conduct and oversight of the execution of Phase 2 - 3 studies, as well as post-approval and life-cycle management studies primarily focused in Womens Health.
This individual will play an important role with assisting Operational teams in executing and tracking deliverables that support the oversight of our clinical trials and Service Providers/vendors to ensure the integrity of our trials.
The project tasks/activities handled by the CTA will support Directors and/or Associate Directors ensuring the consistency of operational aspects of the program/studies. As needed may liaises with internal/external partners, vendors, and vendor management. Will also support the department as needed with specific activities/assignments.
Client is running its development programs through an outsourced and hybrid operational model. In this context the CTA plays an important role in maintaining organization for the teams to align with study and departmental objectives.
This position will report to the Director, Study Management, GCTO Program Manager within Global Clinical Development in the Research and Development organization.
Primary Responsibilities
• Responsible for supporting the Study Management teams, conduct and oversight of our trials
• May interact with the Service Provider/vendors as needed to complete assigned trial support activities to ensure the conduct of clinical trials in line with program objectives are being carried out efficiently
• May be supporting multiple clinical trials
• Will support in the maintenance of study documents and eTMF reconciliation
• Responsible for assisting with the conduct of study team meetings including generation of agenda and minutes
• Responsible for assisting in the review and tracking of various study documents and study plans (such as Site Feasibility Questions, Site Selection Questions, Monitoring Plan, and any other relevant study plans)
• Generation of enrollment and study level metrics reports as needed
• Other duties as assigned to support the business needs of the organization
• May contribute to cross-functional/functional operational excellence initiatives.
Qualifications:
Education / Certificates: • Bachelor’s degree in Life Sciences with minimum 3 or MS in Life Sciences with minimum 1+ year of relevant experience in clinical drug development. Experience • Practical experience working with of Service Providers/vendors for trial conduct • Good level navigation skills in difficult situations Skills (professional and/or technical): • Pharmaceutical and/or clinical drug development experience. • Good organizational skills and ability to manage multiple tasks with meticulous attention to detail. • Strong time management skills. • Strong written and verbal communication, excellent knowledge of computer/database management systems. • Meticulous attention to detail. • Ability to listen effectively and the capability to effectively communicate ideas and data both verbally and in writing in an appropriate manner. • Developing to strong project management skills. • Strong Powerpoint, SharePoint, Excel, Word, Outlook and online meeting tool skills. Competencies: • Ability to think critically, independently and problem solve. • Must have high level of motivation, drive, and demonstration of company leadership values. • Strong interpersonal skills in difficult situations. • Strong active listening skills and ability to articulate and formulate actions in a clear business language. • Ability to work seamlessly with all levels of personnel. • Ability to work well in a team environment, build alignment and maintain positive relationships across teams. • Support and assist with change and innovation. • Demonstrated sensitivity and knowledge of cultural differences with experience in multi- country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations. **CO/NY candidates may not be considered
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Jersey City, NJ
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.