Senior Clinical Trial Manager (Contract)

Cullgen•San Diego, CA

13h•Hybrid

About The Position

Cullgen is seeking an experienced Senior Clinical Trial Manager as a contract to permanent hire. Initially, the role requires approximately 30 hours per week and will increase over the next 6 months to full-time. This role requires a self-motivated person who can manage the start-up and execution of US based clinical trials. The ideal candidate thrives in a fast-paced, small-company environment where daily activities can fluctuate, requiring prioritization, flexibility and the ability to navigate uncertainty. The Senior CTM is accountable for operational planning and execution at the study level with responsibility for the clinical trial planning and execution (start up thru close out), including timeline, quality, and budget. A key focus will be the oversight of and interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission/inspections. The Senior CTM will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries and is expected to provide leadership within and guidance with regards to operational deliverables.

Requirements

Bachelor's degree with a minimum of 5-7 years of experience within the pharmaceutical, biotechnology industry with a minimum of 2 years of experience in Biotech industry strongly preferred.
Two years experience independently managing Phase 1 - 3 trials
Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
Experience working in a fast-paced and dynamic environment

Nice To Haves

Experience in CNS and specifically acute pain trials a plus
Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
Experienced with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
Excellent presentation skills and the ability to present scientific information to varied audiences
Excellent computer skills and standard Microsoft Office Suite (Word, Excel, PowerPoint)
Excellent written, verbal and face-to-face communication to present information internally and externally as needed
Excellent organizational and time management skills
Strong critical thinking and problem-solving skills
Detailed oriented
This is a hybrid-role but candidates should be based in San Diego or west coast, and can occasionally work onsite.
No agencies.

Responsibilities

Accountable for overall management of a Phase 1b/2a acute pain clinical trial
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols.
Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File.
Demonstrates consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors.
Proactively identify and resolve issues that arise during the trial, maintaining a sense of urgency and attention to detail.
Works cross-functionally to establish and ensure clinical trial timelines and goals are met and risks are appropriately escalated to Management.
Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion.
Experienced in developing all Clinical trial plans including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets.
Collaborate with the CRO in the collection, preparation, and review of regulatory documentation prior to study start-up.
Responsible for the set-up of all third-party vendor specifications (i.e. PK analytics/kit build and Drug Depot) and on-time third party deliverables.
Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO.
Responsible for vendor budget, invoice review and study scope changes
Accountable for eTMF – completeness, timeliness, and quality on assigned programs.
Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files.
Responsible for participating in and presenting at Investigator Meetings, SIVs and other program meetings.
Provide monitoring oversight by conducting co-monitoring visits and reviewing CRO monitoring reports and deviations on an ongoing basis.
Support trial-related audits and inspections as needed, ensuring complete and accurate documentation is available.
Demonstrated success in managing teams, including mentoring Clinical Trial Associates or similar roles.
Ability to travel 10-20% to US sites/vendors.