Clinical Trial Manager

Planet Pharma; Massachusetts; Remote; USD 175,000 - 200,000; Full time

Job summary

A leading biotech company is in need of a Clinical Trial Manager for a remote role. This position requires 10-15 years of clinical trial management experience and entails overseeing trial operations, ensuring compliance with regulations, and managing vendor relationships. If you thrive in a dynamic environment and possess extensive experience in managing global clinical trials, consider this opportunity.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 10-15 years of clinical trial management experience.
• Must be on EST time zone.

Responsibilities

• Responsible for all clinical operational aspects for assigned global clinical trial(s).
• Oversee all trial related aspects, timelines, budget and quality.
• Ensure trials comply with procedures, ICH-GCP and applicable regulations.

Skills

clinical trial management

global experience

CRO management

risk management

project oversight

Job description

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Immediate Need for a Remote Clinical Trial Manager with a biotech company. 1 year renewable contract. Will only consider candidates on EST time zone. Must have 10-15 years of clinical trial management experience, global experience and CRO management experience.

The CTM is responsible for all clinical operational aspects for the assigned global clinical trial(s) from preparation until closure. The trial responsibilities include:

• Participate in the clinical trial team meetings, or, in case of a Lead CTM: lead the clinical trial team meetings together with the Lead Trial Physician
• Oversee risk identification and mitigations for the clinical trials, provide solutions and oversee implementation
• Oversee all trial related aspects, timelines, budget and quality. Close collaboration with the CODL on changes, issues and potential solutions
• Ensure that clinical trials are executed according to the Clinical Development Plan (CDP), trial plans, OGSM and in compliance with procedures, ICH-GCP and other applicable legislations
• Support and participate in CRO and vendor selection
• Lead CRO contracts negotiations together with the vendor manager
• Responsible for leading, guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical trial based upon metrics and plan
• Member of the Country and Site Selection Commission for the specific trial
• Provide input into and/or develop trial related materials such as clinical protocol, clinical monitoring plans, data management plan, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, patient retention and recruitment materials
• Oversee and track patient recruitment and pro-actively identifies ways to prevent recruitment delays
• Develop monitoring and site oversight strategy and oversee adherence to it. Perform site oversight visits according to plan
• Review monitoring visit reports, protocol deviations and data listings to ensure reliable quality data are delivered and proactively identify and solve issues/concerns
• Ensure that the Trial Master File (TMF) is maintained and up to date
• Ensure timely availability of investigational product supply on site and ensure clinical site accountability records on site are in place and maintained
• Ensure timely collection, documentation and reporting of Adverse events (AEs) and Serious AEs (SAEs) and collaborate in submission of the reports to FDA, EMEA and other applicable regulatory authorities
• Ensure supportive relationships with clinical sites and trial personnel
• Clearly communicate on goals/expectations and motivate team members, including vendors, to work towards achieving clinical trial goals
• Pro-actively identify and solve issues in the assigned clinical trial and timely escalate them to CODL, Head of Trial Operations and/or Senior Management, as needed
• Responsible and contact person during inspections/audits for the assigned trial together with the Quality Assurance representative
• Identify efficiencies, best practices and lessons learnt. Search for and embrace innovation

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research and Project Management

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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