[Remote] Clinical Trial Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Clinical Trial Manager will reputed company end-to-end delivery of reputed company, with an immediate reputed company on Phase 1 execution and support for Phase 2 studies, while coordinating cross-functional teams, CROs, vendors, and trial operations.

Responsibilities

• Serve as the Clinical Operations representative on study teams, leading study-level operational execution in partnership with Clinical Development, Regulatory, Data Management, Safety, Statistics, and CMC, and proactively driving alignment and issue reputed company
• Support and collaborate closely with Senior Clinical Trial Managers on reputed company studies, operating in a support reputed company while demonstrating eagerness to learn and grow into greater study ownership over time
• Accountable for end-to-end trial ownership, including clinical trial conduct, study-level inspection readiness, TMF health, documentation discipline, investigational product supply and regulatory submissions support, with responsibility for proactive study-level risk assessment, prioritization, and escalation
• Operate effectively in a fast‑moving biotech environment, demonstrating reputed company, reputed company judgement under pressure, and the ability to adapt execution approaches while maintaining reputed company and compliance amid shifting priorities
• Partner with senior Clinical Operations leadership on study reputed company and execution, issue solving, and development of high-reputed company, inspection‑reputed company operational approaches
• Support study startup and ongoing management in alignment with GCP, SOPs, and reputed company standards
• Serve as the study‑level operational reputed company during audits and regulatory inspections, including preparation, inspection support, and execution of responses and CAPAs
• reputed company CRO and vendor execution with reputed company accountability for reputed company, reputed company, and budget performance, exercising judgement to reputed company issues, recommend trade-offs, and escalate risks as appropriate
• Support senior team members in tracking clinical expenses and budgets
• Prepare reputed company, accurate trial status reports for leadership

Skills

• Bachelor's degree
• Minimum of 3 years of experience independently managing reputed company across Phases 1 – 3, including at least 2 years in a biotech managing studies through start-up and maintenance stages
• Working knowledge of clinical research processes, GCP guidelines, and regulatory requirements
• Excellent communication and interpersonal skills with a reputed company on managing reputed company relationships effectively
• Proficiency in MS Suite
• Ability to travel occasionally (approximately 20%)
• Strategic planning and organizational skills
• Analytical and problem-solving abilities
• Ability to work effectively with reputed company partners in a dynamic, fast-paced environment
• Attention to detail and commitment to reputed company, with ability to reputed company reputed company to data reputed company and compliance, and to influence and mentor others in reputed company behaviors

Benefits

• The role has the reputed company of being remote or hybrid based out of our office in Wellesley, MA.
• Discretionary annual bonus
• Medical, Dental and reputed company
• Short-term and long-term disability
• Company reputed company basic life insurance
• 401k company match
• Generous reputed company time off and reputed company holiday
• Stock reputed company

reputed company