Clinical Trials Manager (CTM)

Lyndra Therapeutics

Watertown, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 12/30/2020
  • Website: lyndra.com
  • Company Address: 65 Grove Street, Suite 301, Watertown, MA, 02472

About Lyndra Therapeutics

Lyndra has developed a technology that extends oral drug delivery beyond one week.

Job Description

Lyndra Therapeutics is a clinical-stage biopharmaceutical company that is making daily pills a thing of the past. Our team has developed the first ultra-long acting pill that lasts a week or longer and can provide a wide range of medicines in a familiar oral capsule form. Our near-term focus is on addressing unmet needs where compliance is a documented issue and weekly or monthly doses would improve medication adherence and health outcomes. Lyndra’s current pipeline includes therapies for Alzheimer’s disease, HIV, opioid use disorder, and schizophrenia.

Position Overview

This position will be responsible for the operational management and the oversight of clinical trials within a clinical development program. This individual will be responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. Providing oversight of the CRO and other third party vendors on assigned study. The Clinical Trial Manager will work closely with a Drug supply, Quality, Regulatory, etc., and will report into the Associate Director, Clinical Development Operations.

Responsibilities:

• Assisting in identification and hiring of appropriate CROs and third party study vendors
• Assisting with CRA and third party vendor training on protocols and practices
• Developing and maintaining good working relationships with investigators and study staff
• Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
• Identifying, selecting, and monitoring performance of investigational sites for clinical studies
• Investigating queries, monitoring discrepancies
• Managing investigational product (IP) accountability and reconciliation process
• Negotiating and managing the budget and the payments
• Overseeing performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to Clinical Operations Manager
• Performing clinical data review of data listings and summary tables, including query generation
• Performing initial review of CRO and other third party study vendor invoices and maintain tracking
• Planning and conducting investigator meetings
• Reviewing key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team
• Reviewing or approving of IP release packages
• TMF maintenance
• Tracking and reporting on progress of study including site activation, patient enrollment, monitoring visits
• Writing or contributing to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents

Job Requirements:

• At least 2 years of trial management experience
• At least 6 years of clinical trial experience in Pharmaceutical, Biotech, or a CRO company is required

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.