Senior Clinical Trial Manager (Sr. CTM)
About Inhibikase
Inhibikase is Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of pulmonary arterial hypertension (PAH).
Senior Clinical Trial Manager (Sr. CTM)
We are seeking a dynamic and experienced Senior Clinical Trial Manager. This role requires a self-motivated person who can manage the start-up and execution of large, global 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. Reporting directly to a Director level in Clinical Operations. The Senior CTM is accountable for operational planning and execution at the study or regional level with responsibility for the overall or regional clinical study plan and implementation (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 Global Clinical Operations and guidance with regards to operational deliverables.
Responsibilities
- Accountable for overall or regional management of assigned 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.
- Responsible for accurate drug accountability/reconciliation for investigational product (IP) issued during the trial to the site and at the end of the trial
- Responsible for ensuring sufficient ancillary supplies are available and shipped for the trial (i.e., templates, binders, forms, supplies, etc.)
- Proactively identify and resolve issues that arise during the course of 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. IWRS, eCRF, central laboratory/ECG, etc.) 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.
- 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 25% including possible international travel.
Education and Training
- Bachelor's degree with a minimum of 8-10 years of experience within the pharmaceutical, biotechnology industry with a minimum of 2 years of experience in Biotech industry strongly preferred.
- Experience with Phase 1 and Phase 2 global 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
- Knowledge in cardio-pulmonary therapeutic area relevant to Inhibikase’s portfolio a plus
- Additional Certifications a plus
Skills and Abilities
- Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
- Experienced with the CDISC TMF reference model
- 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
Inhibikase is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, veteran status, or any other status protected under federal, state, or local law.
Please send resumes and expression of interest to: careers@inhibikase.com
Apply Now
Please fill out the form below to submit your application.