Clinical Trial Manager
1 week ago
We are seeking a highly motivatedindividual to join our team as a Clinical Trial Manager (CTM) to maintain andco-ordinate the logístical aspects of clinical trials in compliance with GoodClinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). Theindividual is an integral member of the study team who will facilitateoperational efficiencies in clinical trials, guided by SOPs and ICH-GCP.
Prior to joining, your experiencewill have been from a clinical research organization, hospital or large medicalspecialty clinic, or work at another biopharma. You will be familiar withclinical data and clinical trial terminology, be able to read standard medicalabbreviations that are used in the world of medical practice and clinicalstudies. You will have familiarity with FDA regulations, GCP, essential studydocuments, and key study activities such as; tracking patient screening andenrollment, clinical laboratory sample collection, regulatory documents, andstudy team communications. Problem solving skills will be used daily. And didwe mention - being highly organized is essential.
**Essential Duties and Responsibilities**:
- Managingthe supervision of contracted clinical research organizations, clinicallaboratory vendors, and other outsourced work
- Leadingboth an internal and external/CRO study management team to ensure thesuccessful conduct of clinical trials in accordance with State and Federalregulations, GCP regulations, ICH guidelines, and internal SOPs
- Authoringand reviewing as needed clinical study documents (Informed Consent Forms,Clinical Study Plans, Case Report Forms, etc.). Reviewing and contributing asneeded to Investigator’s Brochure and other supportive regulatory documents
- DrivingIRB/ethics committee and regulatory submissions as needed to support studytimelines
- Effectivelyevaluating qualified study sites, performing site initiation, planning andpresenting at investigator meetings/advisory boards, and implementing studystart up activities, including development of documents related to conduct ofthe study (e.g., investigator binder, pharmacy binder, regulatory binderdevelopment, etc.) in collaboration with the clinical study team
- Managingand reviewing study budgets and investigator grants
- Assessingstudy drug requirements and shipment logistics; contribute to labeling strategy
- Responsiblefor study close-out (CRO, third party vendors and internal close-outactivities, invoice reconciliation for project closure) and ensuring studytimelines are met
- Reviewing,and contributing as needed, to support completion of the Clinical Study Reports
- OverseeingTMF archival, submission and QC activities
- Workingefficiently, both independently and within a team
- Training/mentoringjunior staff by actively participating in documentation, sharing industrystandards, implementation of trial conduct best practices, and lessons learned
- Creation,training, review and approval of clinical operations program specific documents
- Mayassist with the development of any new or updated SOPs/Work practices for thedepartment
- Trainsand mentor junior staff or peer mentorship of new hires
- Managesjunior staff
**Desired Skills & Experience**:
- Bachelor’sDegree required, relevant scientific or health-care related discipline highlypreferred
- Minimumof 4-6 years of clinical trial management experience, including protocoldevelopment, selection and management of CROs and contract vendors, timelinemanagement, and budget management. Prior experience working in thebiopharmaceutical industry is desired
- Thoroughunderstanding and ability to lead a cross-functional team through allactivities in the full clinical study life cycle
- Demonstratedproficiency in management of multi-center international clinical trials (frominitiation to closure)
- Experiencemanaging outsourced work
- Excellentinterpersonal, communication (written and verbal), time management,presentation and organizational skills
- Managementor mentorship experience desired
- Abilityand willingness to travel 5-10% of the time (international and domestic)
**EEOC Statement**:
****To all recruitment agencies: Inozyme Pharma, Inc. does not accept agency resumes. Please do not forward resumes to our job’s alias, Inozyme employees or any other organization location. Inozyme is not responsible for any fees related to unsolicited resumes.
**Full-Time Employee Benefits**:
Inozyme Pharma is pleased to offer a comprehensive and competitive benefits package for the health and well-being of our employees and their families.
- Medical
- Insurance- Dental
- Insurance- Vision
- Insurance- 401K**Flexible Spending**
**Account**
- Life & Disability
- Insurance**Health Reimbursement Account**
- Dependent Care
- Account
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