ReCode Therapeutics, Inc.
Senior Clinical Trial Manager Consultant (CF Program) East Coast
ReCode Therapeutics, Inc., Menlo Park, California, United States, 94029
Summary of Position:
We are seeking an experienced and dynamic Senior Clinical Trial Manager Consultant for ReCode’s RCT2100 CF program. You are a self-motivated leader who implements global clinical operations strategy for ReCode’s programs. You will be responsible for collaborating with Clinical Operations and our cross-functional teams to deliver on ReCode’s mission of powering the next wave of genetic medicines. You will have substantial experience in either rare diseases or genetic medicines such as mRNA, gene therapy, or gene editing.
Responsibilities:
Independently/proactively manage all aspects of clinical trial startup/conduct including CROs, vendors, and key stakeholders.
Accountable for clinical operations startup timelines and working closely with CF Clinical Operations Program Lead to keep internal/external teams on track.
Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
Develop and ensure execution of activities outlined in various study plans (sponsor oversight, monitoring, deviation, training, and study communication plans).
Co-monitor or monitor studies if needed for the program.
Drive communication and escalate issues to CF Clinical Operations Program Lead and Head of Clinical Operations.
Navigate team structure (Study execution meeting and clinical meetings) and decision makers to independently resolve issues and escalate challenges/obstacles effectively.
Participate in supporting program team on key regulatory filings (e.g. US IND, UK MHRA, EU CTIS, etc.) as needed.
Experience managing/collaborating with CROs and other study vendors.
Support Study Execution Team meetings.
Qualifications:
BS/BA required with 7+ years of Clinical Operations experience in biotech/pharma managing Phase 1-3 clinical trials.
Rare disease/orphan drug experience preferred.
Proven track record as Clinical Trial Manager (Global Study Lead experience preferred) in rare disease clinical trials.
Working knowledge of study startup timelines/management and study conduct in the European region in ultra-rare disease indications.
Track record of success in negotiating with CROs and representing the sponsor to internal and external stakeholders (i.e., site/vendor relationships).
Demonstrated knowledge of ICH GCP and thorough knowledge of clinical monitoring procedures.
Strong understanding/experience in rare disease patient recruitment and site/patient engagement strategies.
Highly responsive and proactive team player.
Ability to have a growth mindset when problem-solving complex issues.
Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously.
Excellent communication and interpersonal skills with the ability to collaborate and work effectively in a cross-functional, fast-paced environment.
Champion for change within a fast-growing company/department.
Positive attitude with an emphasis on a team-based problem-solving approach.
Ability to travel for periodic site initiation visits and co-monitoring visits.
Salary Range:
$75-$90/hr
Location:
Remote (East Coast Based)
*Please note that for remote positions, salary may be adjusted for cost of living.
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We are seeking an experienced and dynamic Senior Clinical Trial Manager Consultant for ReCode’s RCT2100 CF program. You are a self-motivated leader who implements global clinical operations strategy for ReCode’s programs. You will be responsible for collaborating with Clinical Operations and our cross-functional teams to deliver on ReCode’s mission of powering the next wave of genetic medicines. You will have substantial experience in either rare diseases or genetic medicines such as mRNA, gene therapy, or gene editing.
Responsibilities:
Independently/proactively manage all aspects of clinical trial startup/conduct including CROs, vendors, and key stakeholders.
Accountable for clinical operations startup timelines and working closely with CF Clinical Operations Program Lead to keep internal/external teams on track.
Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
Develop and ensure execution of activities outlined in various study plans (sponsor oversight, monitoring, deviation, training, and study communication plans).
Co-monitor or monitor studies if needed for the program.
Drive communication and escalate issues to CF Clinical Operations Program Lead and Head of Clinical Operations.
Navigate team structure (Study execution meeting and clinical meetings) and decision makers to independently resolve issues and escalate challenges/obstacles effectively.
Participate in supporting program team on key regulatory filings (e.g. US IND, UK MHRA, EU CTIS, etc.) as needed.
Experience managing/collaborating with CROs and other study vendors.
Support Study Execution Team meetings.
Qualifications:
BS/BA required with 7+ years of Clinical Operations experience in biotech/pharma managing Phase 1-3 clinical trials.
Rare disease/orphan drug experience preferred.
Proven track record as Clinical Trial Manager (Global Study Lead experience preferred) in rare disease clinical trials.
Working knowledge of study startup timelines/management and study conduct in the European region in ultra-rare disease indications.
Track record of success in negotiating with CROs and representing the sponsor to internal and external stakeholders (i.e., site/vendor relationships).
Demonstrated knowledge of ICH GCP and thorough knowledge of clinical monitoring procedures.
Strong understanding/experience in rare disease patient recruitment and site/patient engagement strategies.
Highly responsive and proactive team player.
Ability to have a growth mindset when problem-solving complex issues.
Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously.
Excellent communication and interpersonal skills with the ability to collaborate and work effectively in a cross-functional, fast-paced environment.
Champion for change within a fast-growing company/department.
Positive attitude with an emphasis on a team-based problem-solving approach.
Ability to travel for periodic site initiation visits and co-monitoring visits.
Salary Range:
$75-$90/hr
Location:
Remote (East Coast Based)
*Please note that for remote positions, salary may be adjusted for cost of living.
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