Clinical Trial Assistant

Planet Pharma

3+ years

Not Disclosed

Remote, USA

10 May 21, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Project Manager

Major Accountabilities:

Project Planning, Management, and Oversight:
- Develop project plans and manage timelines for Clinical contributions to CV initiative.
- Draft core team meeting agendas and ensure meeting outcomes are captured.
- Contribute to management presentations highlighting scope, timeline, risks, and mitigation steps.
System Specifications:
- Participate in workshops and meetings to document application requirements.
- Translate requirements into use cases and advocate for high priority needs of end users.
Process Flows:
- Determine how deployment of system functionality affects existing business processes.
- Ensure any major process implications are understood and vetted in advance.
Reporting:
- Ensure standard reports within applications are specified, tested, and functioning.
- Interface with core team and end-users to enable timely operational oversight.
System Design & Configuration:
- Interface with technical development team to ensure specifications are understood.
- Lead review of initial prototypes and advocate for end users to ensure high priority requirements are met.
System Testing and Release:
- Provide input to testing plan and ensure applications meet desired requirements.
- Partner with core team on clear go/no go criteria for system release to production.
Training:
- Provide input to training and change management plan and aid in coordination of training sessions.
Desk Side Support:
- Provide desk side support to answer user questions and log system "bugs" for remediation.
Communication Plan:
- Develop communication plan to keep stakeholders informed of clinical trial management activities.

Qualifications:

Experience: Minimum of 3 years of experience in clinical operations or related field.
Education: Bachelor's degree in a scientific or healthcare-related field, or equivalent experience.
Software Proficiency: Proficient in using Clinical Trial Management Systems, preferably Veeva CTMS, and electronic Trial Master File (eTMF) software, preferably Veeva eTMF.
Skills:
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication skills.
- Ability to work collaboratively in a cross-functional team environment.
- Knowledge of Good Clinical Practice (GCP) and applicable regulations.
- Familiarity with country-specific regulatory requirements and site-level operational challenges.
Certification: Certification is a plus, at least some significant experience with Veeva is required.

Employer-provided:

Pay Range in United States: Exact compensation may vary based on skills, experience, and location.

Base Salary: $43/hr - $45/hr

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