Clinical Trial Manager-Consultant
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AI Summary
The role involves supporting end-to-end clinical trial execution, including site selection, protocol development, and monitoring visits. It also requires overseeing CRO performance and ensuring site compliance with GCP and regulatory requirements.
WHY JOIN MILESTONE
At Milestone, we aspire to advance and implement paradigm shifts for cardiac therapy. We are currently focused on developing anti-arrhythmia treatments for self-administration outside of the emergency department or hospital setting for patients with acute episodes of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation (AFib), as well as other episodic cardiovascular conditions.In addition to our science and innovation, we are a team guided and driven by our core values. Patient needs and empowerments are continually upheld as central to our mission. Our teamwork is strengthened in an environment in which we support and challenge each other while enjoying and celebrating our achievements. We maintain an entrepreneurial, proactive, and action-oriented mindset that places high value on grit, courage, and resolve.
Decision-making is based on evaluating information and an idea’s merits; data-driven proposals are both supported and sought. We act individually and as a team with humility, candor, empathy, and unwavering integrity.
We have been successful in attracting and empowering best-in-class talent, and we seek those with passion to join on our journey to develop treatments and to motivate change. We are excited about possibilities of this team and what we can accomplish together.
YOU WILL BE RESPONSIBLE FOR:
- Supporting end-to-end clinical trial execution, ensuring delivery against timelines, quality standards, and budget;
- Assisting in start-up activities of clinical research studies including Investigator site selection;
- Contributing to development of clinical protocols and study documents including informed consent forms, study logs, study manuals, study plans, case report forms and guidelines;
- Assisting in development of training materials and training of CRAs and other CRO personnel;
- Attending co-monitoring and/or training visits at clinical sites as required;
- Attending and co-monitoring studies (PSV, SIV, IMV, COV) as needed;
- Managing investigational product accountability and reconciliation processes;
- Reviewing site and patient activity tracking data, preparing study updates and enrollment metrics and proactively identifying and resolving study-related issues;
- Overseeing performance of CROs, third-party vendors and CRAs to ensure compliance with study protocol and scope, identifying concerns and escalating to the Clinical Team;
- Reviewing Monitoring Visit Reports and escalating findings to the Clinical Team;
- Guiding investigative site activities across multiple clinical trial sites, including but not limited to, SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability.
- Ensuring site compliance with GCP and federal and applicable local regulatory requirements;
- Developing and maintaining excellent working relationships with investigators and study staff.
- Conducting all work in accordance with Milestone SOPs, ICH GCP guidelines, and applicable regulations, and practices continuous improvement
- Interested in 1 Year Contractor / Consultant engagement with hourly or monthly payment terms negotiable
- Bachelor’s degree or equivalent with a minimum of two-years’ experience in clinical development and operations, including experience monitoring at clinical sites;
- Preferred experience is from a pharma sponsor or CRO;
- Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring and regulatory compliance;
- Demonstrated effectiveness in resolving site management issues of varying complexity;
- A resourceful, confident professional with strong communication and interpersonal/ team skills;
- Strong initiative and can-do attitude, with the ability to prioritize and multitask effectively; and
- Demonstrated ability to identify and resolve issues and effectively manage timelines
Able to travel frequently averaging 50% ordinarily, and up to 75% during critical periods; domestic and international travel required. Visits to the Charlotte offices for meetings required.
*Candidates who live near Charlotte, NC, in the future are preferred. However, this position can be filled remotely. All qualified candidates are encouraged to apply and will be considered.
EEOC STATEMENT: Milestone believes in a diverse environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Milestone will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
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