Senior Clinical Trial Manager Consultant

2 months ago

Menlo Park, United States ReCode Therapeutics Full time

Who We Are:

ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode’s lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.

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 that implements global clinical operations strategy focused for ReCode’s CF program. 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 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 and drive clinical trial recruitment activities. 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, EU CTIS, UK MHRA) as needed. Experience managing/collaborating with CROs and other study vendors.

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 US region in rare disease indications. Track record of success in negotiating with CROs and representing the sponsor to internal and external stakeholders (ie site/vendor relationships). Demonstrated knowledge of ICH GCP and thorough knowledge of clinical monitoring procedures. Broad Vendor management experience with CROs and core clinical trial vendors (imaging, home health, patient concierge, patient recruitment vendors). Strong understanding/experience in rare disease patient recruitment and site/patient engagement strategies. Highly responsive and proactive team player. Ability to have 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 team-based problem-solving approach. Ability to travel for periodic site initiation visits, and co-monitoring visits.

Salary Range: $75-$90/hr

Location: Menlo Park, California (Hybrid or Remote)

*Please note that for remote positions, salary may be adjusted for cost of living

Benefits Offered for Full-Time Employees: 

No premium cost for employees - 100% subsidized by ReCode for full-time employees Company 401k contribution 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year) Mental health support for employees & their families FSA available, including a lifestyle spending account subsidized by company Employee discounts at hotspots

ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.

ReCode Therapeutics is an Equal Opportunity Employer.

  • Senior Clinical Trial Manager Consultant

    3 weeks ago

    Menlo Park, United States BioSpace, Inc. Full time

    Job Details Who We Are: ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs,...

  • Clinical Trial Manager

    4 weeks ago

    Menlo Park, California, United States Summit Therapeutics Full time

    Clinical Trial Manager Job DescriptionAt Summit Therapeutics, we are seeking a highly experienced Clinical Trial Manager to lead our global clinical operations team. As a key member of our team, you will be responsible for the overall management of clinical trials, from study start-up to close-out. Your expertise will ensure the successful delivery of...

  • Clinical Trial Manager

    1 month ago

    Research Triangle Park, United States Worldwide Clinical Trials - USA Full time

    Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are Worldwide Clinical Trials, and we are a global...

  • Senior Manager, Statistical Programming Lead

    4 weeks ago

    Menlo Park, California, United States Summit Therapeutics Full time

    Job Summary:The Senior Manager, Statistical Programming will be responsible for leading and managing the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies. This role will oversee the development and implementation of statistical programming strategies,...

  • Clinical Site Manager

    1 week ago

    Menlo Park, United States May Health Full time

    Position SummaryThe Clinical Site Manager is a hybrid position responsible for:leading, assisting, and providing site management support for clinical sites during study start-up, enrollment, maintenance, and close-out. leading and providing technical case support and physician training within an investigational medical device clinical...

  • Clinical Site Manager

    2 weeks ago

    menlo, United States May Health Full time

    Position SummaryThe Clinical Site Manager is a hybrid position responsible for:leading, assisting, and providing site management support for clinical sites during study start-up, enrollment, maintenance, and close-out. leading and providing technical case support and physician training within an investigational medical device clinical...

  • Senior Clinical Research Coordinator

    3 weeks ago

    Overland Park, United States Aquent Full time

    12month+AssignmentPay Range: $50.46 to $56.06 an hourThis is an ONSITE Position 5 days per week, not remoteThe Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned...

  • Senior Clinical Research Coordinator

    1 month ago

    overland park, United States Aquent Full time

    12month+AssignmentPay Range: $50.46 to $56.06 an hourThis is an ONSITE Position 5 days per week, not remoteThe Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned...

  • Senior Clinical Research Associate

    1 week ago

    Menlo Park, United States May Health Full time

    Position SummaryThe Sr. Clinical Research Associate is responsible for leading, assisting, and providing monitoring and site management support for clinical sites during study start-up, enrollment, maintenance, and close-out.ResponsibilitiesLead or support assigned clinical trial sites(s) during start-up, ongoing activities, close-out, and reporting.Assist...

  • Sr. Clinical Data Manager

    1 week ago

    Menlo Park, United States TechData Service Company LLC Full time

    Job DescriptionJob DescriptionOverview of Role:We are seeking a highly skilled Senior Clinical Data Management (CDM) Contractor with extensive experience in oncology studies, particularly in late-phase trials and regulatory submissions. This role demands hands-on expertise in optimizing data management processes, ensuring data quality, and facilitating...

  • Senior Trial Attorney

    4 days ago

    Buena Park, California, United States THE SOUD LAW FIRM Full time

    Job OverviewThe Soud Law Firm is seeking an experienced Senior Trial Attorney to join our team in North Florida.This role offers a unique opportunity for a skilled negotiator and lawyer to handle complex cases, supervise support staff, and oversee a large caseload with assistance.

  • Associate Director, Field Clinical Operations

    1 week ago

    Menlo Park, United States May Health Full time

    Position SummaryThe Associate Director, Field Clinical Operations is a hybrid position responsible for:Leading, assisting, and providing site management support for clinical sites during study start-up, enrollment, maintenance, and close-out.Leading and providing technical case support and physician training within an investigational medical device clinical...

  • Senior Clinical Research Associate

    2 weeks ago

    menlo, United States May Health Full time

    Position SummaryThe Sr. Clinical Research Associate is responsible for leading, assisting, and providing monitoring and site management support for clinical sites during study start-up, enrollment, maintenance, and close-out.ResponsibilitiesLead or support assigned clinical trial sites(s) during start-up, ongoing activities, close-out, and reporting.Assist...

  • Senior Business Transformation Manager

    4 weeks ago

    Menlo Park, California, United States Genesys Cloud Services, Inc. Full time

    Genesys Cloud Services, Inc. is seeking a seasoned Senior Business Transformation Manager to spearhead our enterprise-wide transformation initiatives.This pivotal role will shape the company's future by implementing innovative solutions, fostering a culture of continuous improvement, and ensuring alignment with our strategic goals.The ideal candidate will...

  • Associate Corporate Counsel

    4 weeks ago

    Menlo Park, California, United States Oruka Therapeutics Full time

    About UsOruka Therapeutics is a biotechnology company dedicated to developing innovative treatments for chronic skin diseases. Our mission is to provide patients with the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year.Job Title: Associate Corporate...

  • Trial Attorney

    7 days ago

    Forest Park, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Senior Clinical Scientist

    4 weeks ago

    Menlo Park, California, United States GE Healthcare Full time

    Senior Clinical Scientist - Advanced Imaging ExpertAt GE Healthcare, we're committed to improving lives and advancing the field of healthcare through innovative technology and solutions. We're seeking a highly skilled and experienced Senior Clinical Scientist to join our team and contribute to the development and implementation of cutting-edge imaging...

  • Trial Attorney

    7 days ago

    Pinellas Park, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    1 week ago

    Lincoln Park, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...

  • Trial Attorney

    7 days ago

    Allen Park, United States State Farm Full time

    OverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...