$100K — $150K *
We are seeking a Clinical Trial Manager/ Senior Clinical Trial Manager to serve as the operational project lead for a Phase 1 study in patients with advanced malignancies including project planning, budget and resource management, and oversight of the Contract Research Organization(s) and project vendors. This person works closely with the Alpine Medical Director and the Associate Director of Clinical Operations to lead a cross-functional team to ensure the timely, quality conduct of an oncology trial in accordance with the protocol Good Clinical Practice, Standard Operating Procedures, and applicable regulations.
· Manages all aspects of the clinical operational plan for the study, including all manuals, forms, plans and documents.
· Aligns study start-up, enrollment, study conduct, and close-out activities with project goals and timelines
· Works closely with the project team to develop the clinical trial protocol and design all associated clinical forms, including Case Report Forms, SAE Forms, etc. for assigned clinical trial
· Ensures compliance with good clinical practices, good manufacturing practices, and global regulatory guidelines.
· Recommends and implements innovative processes to improve and impact clinical trial management and deliverables.
· Oversees the development of study plans and manuals, and conducts internal team meetings
· Works closely with the medical director and CRO to plan and execute investigator meetings
· Helps develop and manage clinical budgets, contracts, and contingency plans for clinical trials.
· Works with the biometrics group to create and implement study-specific tools to ensure clean data and timely data entry
· Responsible for managing full scope of study, protocol and clinical study report.
· Acts as a cross functional liaison to ensure study plan aligns with business development strategies.
· Responsible for managing overall study budget, including review of vendor invoices for accuracy.
Desired Skills and Experience:
· University degree and a minimum of 6 years of clinical trials experience, including clinical trial management, in pharmaceutical, biotech or CRO setting and clinical trial management experience.
· Experience in Phase I-III clinical trials, including multi-national studies.
· Demonstrated successful management of CROs and vendors
· Oncology study experience required.
· Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
· Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.
· Thorough knowledge of CFR and GCP/ICH requirements.
· Exceptional attention to detail.
· Proficiency with MS Office products Word, Excel, PowerPoint, Share point
Valid through: 2/25/2021
$80K — $100K
4 days ago