Jobs Companies Egenesisbio Senior Clinical Trial Manager

Über diese Senior Clinical Trial Manager Stelle bei Egenesisbio

Egenesisbio · Hybrid · Cambridge, MA
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. 

POSITION SUMMARY

eGenesis is seeking a resourceful and collaborative Senior Clinical Trial Manager to join our Clinical Operations team to support programs across our portfolio. This role will work closely with our teams across Regulatory, Quality, GMP Production, and Development to successfully drive our clinical programs. As the Senior Clinical Trial Manager, you will be responsible for the day-to-day management of our clinical studies, vendors, and sites in alignment with corporate and program goals. You will work closely with clinical sites and CROs to ensure compliance with SOPs and regulatory guidelines. To be successful in this role, you will leverage a passion for the details, excellent communication skills and an eagerness to collaborate.

PRIMARY RESPONSIBILITIES

  • Assist in overall management of clinical trials, including but not limited to managing study timelines and budgets as well as providing CRO and other external vendor oversight
  • Assist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, study plans, lab manuals, Case Report Forms, Clinical Study Reports, and other study level documents
  • Engage cross-functionally to ensure clear, consistent communication to key stakeholders on study status, metrics and timelines
  • Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
  • Serve as a point of contact for CRO and clinical site communication
  • Assist in the set up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial, including periodic reviews
  • Lead internal study team calls and ensure appropriate cross functional follow up and resolution to tasks in a timely manner
  • Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation including central clinical files
  • Proactively identify risks in study timelines in regard to key milestones and deliverables and work closely with the cross-functional teams to mitigate downstream impacts
  • QUALIFICATIONS

  • Bachelor’s degree, life science or medical background preferred
  • 7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
  • Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
  • Strong interpersonal and organizational skills are needed, with a high degree of attention to detail with ability to flex communication style to all areas of the organization
  • Working knowledge of Good Clinical Practices (GCP) and other relevant regulatory requirements
  • Ability to travel up to 10% of the time
  • Ability to be onsite in the Cambridge office 2 days per week
  • Base pay range for this job is $142,800 - $176,400.
    Bereit, sich bei Egenesisbio zu bewerben?
    Bei Egenesisbio bewerben

    Wie sich dieses Gehalt für Clinical Trial vergleicht

    Diese Stelle zahlt $159,600/yrim Einklang mit der üblichen Spanne für Clinical Trial Stellen.

    $110,000 dem Median $157,500 $180,000

    Übliche Spanne $139,250–$170,225/yr, aus 31 vergleichbaren Clinical Trial Anzeigen auf JobsRadar (Vergütung auf USD hochgerechnet). Gehaltseinblicke für Clinical Trial ansehen →

    Ähnliche Jobs

    Artbio
    Senior Clinical Trial Manager
    Artbio
    ⚡ Früh bewerben Cambridge, MA Vor Ort
    ● Neu 👁 Gesehen ✓ Beworben vor 1 Wo.
    Sana Biotechnology
    Senior Clinical Trial Manager, Patient Support Operations
    Sana Biotechnology
    ⚡ Früh bewerben Cambridge, MA Vor Ort $160,000–$200,000
    ● Neu 👁 Gesehen ✓ Beworben vor 3 Wo.
    PR
    Client Services Manager, Clinical Trial
    Prolaio
    ⚡ Früh bewerben Chicago, IL Hybrid $115,000–$115,000
    ● Neu 👁 Gesehen ✓ Beworben vor 3 Tg.
    Maze Therapeutics
    Trial Master File Sr. Manager, Clinical Operations
    Maze Therapeutics
    ⚡ Früh bewerben South San Francisco, CA Vor Ort $175,000–$215,000
    ● Neu 👁 Gesehen ✓ Beworben vor 3 Tg.
    Attovia Therapeutics
    Clinical Trials Associate
    Attovia Therapeutics
    ⚡ Früh bewerben San Carlos, CA Vor Ort
    ● Neu 👁 Gesehen ✓ Beworben vor 4 Tg.
    HE
    Clinical Trial Manager - East Coast
    Heartflow
    ⚡ Früh bewerben Philadelphia, Pennsylvania; Ne... Vor Ort $95,000–$125,000
    ● Neu 👁 Gesehen ✓ Beworben vor 4 Tg.
    Rapport Therapeutics
    Senior Clinical Trial Manager
    Rapport Therapeutics
    ⚡ Früh bewerben 99 High Street, Suite 2100 , B... Vor Ort
    ● Neu 👁 Gesehen ✓ Beworben vor 5 Tg.
    Revolution Medicines
    Clinical Trial Manager
    Revolution Medicines
    ⚡ Früh bewerben Redwood City, California, Unit... Vor Ort $120,000–$150,000
    ● Neu 👁 Gesehen ✓ Beworben vor 5 Tg.
    Alimentiv
    Clinical Operations Lead (Clinical Trial Manager) (India)
    Alimentiv
    ⚡ Früh bewerben Delhi · standortgebunden
    ● Neu 👁 Gesehen ✓ Beworben vor 6 Tg.

    Registrieren für Vorschläge, die auf die von Ihnen geöffneten Jobs und gespeicherten Suchen zugeschnitten sind.

    Mehr Jobs bei Egenesisbio

    Alle Jobs bei Egenesisbio ansehen →

    Jetzt bewerben
    🤖

    Moment — langsam

    JobsRadar wurde für echte Menschen gebaut, die eine schwere Zeit bei der Jobsuche haben — nicht für automatisierte Anfragen. Sie klicken viel zu schnell und sind jetzt vorübergehend blockiert.

    Kommen Sie später wieder. Wenn Sie wirklich auf Jobsuche sind, stehen wir hinter Ihnen — verhalten Sie sich einfach wie ein Mensch.

    Catch your next role the second it’s posted.

    Create a free account and we’ll watch the boards for you — the instant a job matches your search, it lands in your inbox or Telegram. No digging, no refreshing.

    Create free account

    Free forever · takes 30 seconds · already have one?

    Verschaffe dir einen Vorsprung bei der Jobsuche.

    Tritt unserem Telegram-Kanal bei für das, was dir hilft, die Stelle zu bekommen — Gehaltsbenchmarks, den wöchentlichen Marktpuls und neue Feature-Drops. Kein Spam, nur Signal.

    Dem Kanal beitreten — kostenlos