Senior Clinical Trial Manager

🕒 April 24

🏄 California – Remote

🏄 California – Remote

💵 $130k - $160k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Angitia Biopharmaceuticals

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $46M Series B on 2023-10

Biotechnology • Healthcare Insurance • Pharmaceuticals

Angitia Biopharmaceuticals is a clinical-stage biotechnology company founded in 2018, focused on the discovery and development of breakthrough therapeutics for serious musculoskeletal diseases. With a strong emphasis on innovation, Angitia aims to address unmet medical needs through their pipeline of therapeutics, including treatments for conditions such as Osteogenesis Imperfecta and Osteoarthritis. The company is devoted to fostering a culture of respect and equality, and is committed to employee growth and career development while delivering effective therapies to help patients in need.

📋 Description

• Lead the cross-functional Study Management Team (SMT) to ensure objectives of the Clinical Development Plan (CDP) are met and that deliverables are completed on time and within budget. • Oversee the identification, selection, on-boarding, and management of study vendors including CROs, central /specialty labs, and imaging vendors etc. • Main point of contact for Full-service CRO, including all sub-contracted activities. • Provide study-specific training and direction/oversight to vendor personnel to ensure study delivery per the scope of work and key performance indicators. • Oversee and partner with external and internal stakeholders to ensure clinical trial data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise ‘quality assured’. • Contribute to clinical operations deliverables by providing updates (e.g. DSUR/Annual Report, IBs, protocols, ICFs, CRFs, and CSRs). • Review and approve study management plans (e.g. vendor oversight, TMF oversight, risk management, quality management, and monitoring), and ensure team adheres to plans and conducts studies in accordance with ICH GCP and applicable regulations. • Timely review and approval of invoices, monthly accruals, and forecast budget variances. • Review and approve monitoring reports per monitoring plan and escalate as needed. • Track key study activities using tracking tools. • Identify issues and risks and propose potential resolutions.

🎯 Requirements

• BS/BA (or equivalent) in a relevant scientific discipline; advanced degree desirable. • 6+ years of relevant industry experience in clinical drug development (at least 3 years of CRA experience, 2 years of study management experience). • Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring. • Strong experience in management of CROs and other vendors. • Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies. • Experience leading global clinical research activities, both early and late development experience preferred. • Exceptional project management, cross-functional team leadership, and critical thinking and organizational skills. • Excellent interpersonal, written and verbal communication skills. • Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project Management. • Effective team player and ability to influence and collaborate with cross functional clinical study teams. • Strong leadership skills, self-motivated, adaptable to a dynamic environment. • Ability to make decisions, set priorities, and share resources to benefit the whole organization. • Strong analytical skills with a data driven approach to planning, implementing, and problem solving.

🏖️ Benefits

• Medical, dental, and vision coverage for employees and their eligible dependents • 401(K) Retirement Plan with Company match • Company paid Long Term Disability Coverage • Company-paid life Insurance & AD&D Coverage • Voluntary Life Insurance & AD&D Coverage • Employee Assistance Program (EAP) • Company-paid Holidays • Vacation • Paid Sick Leave • Telecommunication Monthly Stipend • Work-From-Home Equipment Reimbursement