Clinical Trial Manager

Cutting-edge biotech with patented science, great funding and strong pipeline.

This Jobot Job is hosted by: Keegan Wade
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $115,000 - $150,000 per year

A bit about us:

Cell-based therapy biotech with strong pipeline, experienced leadership and good funding.

Why join us?

Unique opportunity to work with some of the most established leaders in this space. Work hand-in-hand with a VP of Development to managed strong pipeline in Phase I and II. Clear path for growth and excellent science, all while being remote based.

Job Details

Position Description
The Manager, Clinical Operations manages one or more clinical studies from Protocol Concept to Clinical Study Reporting and Disclosure. This is an exciting opportunity for an individual with a proven track record of managing studies, including internal cross-functional collaboration and coordination, CRO and vendor management to join a dynamic team working to deliver high quality studies on time and within budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and standard operating procedures.

Essential Duties & Responsibilities

• Managing study progress from start-up to close-out activities and end of study reporting.
• Assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs, identifying risks and implementing risk mitigation plans.
• Coordinating interdisciplinary activities throughout the study.
• Oversight and management of CRO and clinical vendors as appropriate to ensure successful conduct of the clinical trial and to ensure data integrity and quality.
• Oversight and management of multiple clinical trials from early development through licensure.
• Lead completion of study deliverables through active participation in all aspects of study design, execution, analysis and reporting, vendor selection and management, and oversight of investigator selection and management.
• Proactively managing study deliverables and milestones, including identifying and resolving trial related issues (quality, timelines, budget, resources).
• Writing clinical related deliverables (e.g., Investigator Brochure, clinical protocol/amendments, Annual Reports/DSUR, eCTD clinical modules, response to FDA questions, etc.)
• Ensure audit readiness at all times by assessing and mitigating study compliance with all regulatory requirements (knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management is required)
• Participate in process improvement initiatives including, but not limited to, contributing to generation of Standard Operating Procedures (SOPs), and collaboration with Clinical Quality and Laboratory staff on study compliance initiatives.
• Provide input in the development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, timelines, monitoring plans, laboratory manuals, training materials, and site initiation visit slide presentation
• Effective communication with KOLs and Investigator site staff to support study delivery.
• Contributing to individual and team development through training initiatives and team building activities

Qualifications:

• Bachelor's degree in biological science, nursing, pharmacy or equivalent as a minimum.
• Minimum 5 years of experience in the pharmaceutical industry in a position performing clinical operations functions.
• Proven track record as a clinical study manager including internal cross-functional coordination and CRO and vendor management to deliver high quality studies to time and budget.
• Previous pharma industry experience Managing early through late studies with preference to early phases.
• Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges.
• Must possess excellent project planning and priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate to rapidly changing priorities and deadlines.
• Solid project and vendor management, analytical and problem-solving skills.
• Prior experience with forecasting, tracking and reconciliation of study budgets.
• Prior experience with authoring and coordinating the development of clinical protocols, Investigator brochures and study reports.
• Excellent written and verbal communication skills.

Schedule:

• Monday to Friday

Work Location:

• Remote

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