Clinical Trial Manager
Mahana Therapeutics is a venture-backed healthcare company creating software-based treatments for patients living with chronic conditions. Mahana relies on an interdisciplinary team to develop best-in-class treatments. The team is an exciting blend of accomplished healthcare and consumer technology entrepreneurs, software engineers, designers, clinical researchers, psychologists, and physicians.
Key responsibilities will include the planning and implementation of clinical development programs for Mahana products. Importantly, successful candidates will possess significant, relevant experience in clinical project management and operations, as well as excellent writing and presentation skills, be detailed-oriented and possess the ability to carry out multiple tasks while maintaining a high level of quality.
This role reports to the VP of Clinical Innovation and requires strong interpersonal and verbal communication skills. The ideal candidate will thrive in an energetic, fast-paced environment, working with highly motivated and passionate people.
- Oversee clinical program execution, ensuring adherence to budgets and timelines, while delivering exceptional quality.
- Perform investigative site outreach, feasibility, and oversee selection, qualification, and contracting of sites, as well as training of site staff.
- Develop and implement project plans in accordance with Mahana SOPs and clinical protocols.
- Lead the coordination between various functional groups working to execute the clinical tria.l
- Support outsource and resource planning for clinical programs inclusive of development of Requests for - Proposal (RFPs); vendor qualification, selection, and contracting; and determination of need for contract staff to support clinical trial activities.
- Manage all vendors and ensure that contracted scope of work is performed in accordance with agreements and study plans, all applicable regulations, and with a high level of quality.
- Coordinate site management activities, including monitoring and regulatory document collection.
- Identification, training, and mentorship of clinical monitors, and perform co-monitoring/oversight to ensure their compliance with GCPs and Mahana Standard Operating Procedures (SOPs); additionally, CTM will define and implement standards, goals and expectations for clinical operations staff (in-house, contract, and/or outsourced).
- Perform routine risk identification and mitigation.
- Support preparation of vendor and site agreements, contracts, and budgets/payment terms.
- Assist with Institutional Review Board submissions and communication.
- Provide periodic updates on study metrics/key performance indicators (KPI) to Mahana executive leadership.
- Ensure clear clinical program team communication, process documentation, and compliance with Good Clinical Practice and Mahana SOPs.
- Work closely with Mahana patient advocacy lead to support clinical trial awareness and patient identification initiatives across the portfolio to support both product development and rapid trial enrollment and execution.
- Passion for patients and clinical research to advance available treatment options
- Robust knowledge of ICH GCP and other regulations governing execution of clinical trials
- Ability to anticipate and plan for potential issues in trial execution, and to proactively implement risk mitigation strategies
- Strong verbal and written communication skills
- Ability to think analytically and convey complex ideas to various audiences
- Experience designing and implementing eClinical systems (e.g., electronic data capture [EDC], etc.) preferred.
- Excellent writing and presentation skills; superior organizational and budgeting skills; detail-oriented
- A positive mental attitude and team orientation
- In-depth knowledge of all aspects of clinical trial execution, inclusive of basic understanding of supporting functions and their deliverables (e.g., Data Management, Biostatistics and Programming, Medical Writing)
- Ability to implement corrective actions as needed to maintain project performance, quality, and data integrity
- Excellent organizational and interpersonal skills
- Advanced user of MSOffice Suite (e.g., Word, Excel, Project)
- Able to work independently as well as collaboratively, with a sense of urgency, in a matrixed environment
- BS/BA (or equivalent) in one of the life sciences, as well as 5+ years of direct experience in Sponsor-side clinical trials management and/or clinical operations roles
- Excellent strategic thinking skills, and successful track record of executing clinical studies on time, and within allocated budget
Mahana Therapeutics is an equal opportunity employer.
Note to Recruitment Agencies: Please do not forward any agency resumes. Mahana Therapeutics is not responsible for any fees related to resumes that are unsolicited.