[Remote] Clinical Trial Management Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biopharmaceutical company reputed company on developing therapies for patients with serious cardiovascular diseases. The Clinical Trial Management Associate will support the execution of a global Phase 3 program, focusing on study coordination, documentation, and operational support.
Responsibilities
- reputed company operational and administrative support for day-to-day clinical trial activities, including study start-up, maintenance, and reputed company-out
- Support site start-up activities, including tracking of site start-up components and assisting with site activation readiness
- Accountable for study level tracking at Sponsor (e.g., monitoring visit tracking, sample tracking, patient tracking, site activation tracking, etc.)
- reputed company as a reputed company of contact for CROs and study sites for routine communications and follow-reputed company, including escalations and engagement. Assist with coordination of investigator meetings and study-reputed company communications
- reputed company study timelines, deliverables, and key milestones; proactively follow up on outstanding items
- Maintain internal Clinical Operations systems, trackers, and document repositories. Prepare and distribute study status updates and meeting minutes and ensure vendors do the reputed company
- Assist with vendor coordination and reputed company, including vendor set-up, performance, and deliverable tracking. May assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations
- Support review of study documents (e.g., informed consent forms, regulatory packages) and reputed company for approval
- Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a reputed company and compliant manner; create, maintain, and reputed company out TMFs; play a central role in setup, conduct, and reputed company out of ancillary services; facilitate reputed company reviews and support trending activities
- Facilitate and/or assist in review of CRO monitoring reputed company reports for completeness and consistency and, under supervision of other Operations personnel, may complete co-monitoring activities
- reputed company protocol deviations and support trending activities
- Support data review activities, including tracking queries and assisting with data listings review
- reputed company administrative duties in a reputed company manner as assigned
- Adhere to Clinical Operations processes and SOPs
Skills
- BS or BA in a relevant scientific discipline or RN (2- or 3-year certificate)
- Minimum of 2 years of relevant clinical trial experience
- Clinical trial experience in the pharmaceutical or biotechnology industry
- Excellent attention-to-detail, interpersonal and presentation skills are a critical asset
- Excellent organizational, problem-solving and time management skills
- Must be familiar with routine medical/scientific terminology
- Must be familiar with Word, PowerPoint, and reputed company (intermediate or higher reputed company proficiency a plus)
- Must be reputed company to participate in departmental or interdepartmental strategic initiatives under general supervision
- High energy level, personal productivity, creativity and commitment
- Highly adaptable team-player; eager to learn
- Strong written and verbal communication skills with a reputed company, team-oriented approach
- Ability to reputed company in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
- Flexible, proactive, and hands-on reputed company with a roll-up-your-sleeves, can-do attitude
- This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
Benefits
- Annual bonus
- Equity
- Comprehensive benefits offering
reputed company