Sr. Manager, Clinical Operations

CorMedix Inc•Berkeley Heights, NJ

59d

About The Position

If you are interested in joining an entrepreneurial team, focused on bringing life-saving therapies to market for critical unmet medical needs, consider applying for a role at CorMedix + Melinta. The culture at CorMedix + Melinta is patient-centered where we feel a sense of urgency to solve some of the most pressing issues in hospital-based healthcare. CorMedix + Melinta's greatest asset is our people. We have a deeply experienced team and continue to bring on some of the brightest talent that can problem solve and execute with high-precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose. We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath (taurolidine and heparin) for the prevention of catheter related bloodstream infections in patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products including MINOCIN (minocycline), REZZAYO (rezafungin), VABOMERE (meropenem and vaborbactam), ORBACTIV (oritavancin), BAXDELA (delafloxacin), and KIMYRSA (oritavancin), as well as TOPROL-XL (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. The completion of the Phase III study for REZZAYO is expected in 1H 2026. For more information visit: www.cormedix.com or www.melinta.com Reporting to the Director, Clinical Operations, the ideal candidate would be someone who thrives in a small, fast-paced environment and wants to play a key role in moving Clinical Operations forward wear wearing multiple hats. Primarily focused on CRA management and ensuring the integrity of the monitoring process is protected, the candidate brings a unique blend of experience and skill. This is an opportunity to be part of a pivotal program and to see effective management produce critical results.

Requirements

A positive, forward-thinking attitude
Excellent organizational skills; including tracker building and maintenance
Strong leadership, mentoring and motivational skills
Proficient knowledge of MS Office software
Master-level monitoring and site management skills
20% travel requirement
Bachelor's degree in Science, Nursing or Pharmacy or similar
10+ years clinical operations experience; including roles as a Clinical Research Associate (CRA), Monitoring Manager, Clinical Operations Manager or similar/Clinical Trial Manager/Study Management
Working high-level knowledge of ICH/GCP and CFR 21 and Part 11
Ability to effectively and succinctly communicate key messages to Senior Leadership

Responsibilities

Direct, hands-on oversight of daily CRA operations
Induction of new CRA's (onboarding, training, SOP requirements)
Conduct oversight visits to assess CRA performance
Involvement in the interview and selection process of CRA's
Assist in audit preparation activities
Work closely with Director, Clinical Operations and others to develop meeting and training materials, guidelines, templates, etc.
Develop and directly manage study metric trackers; including monitoring visit report tracker, protocol deviation tracker, action item follow-up, with support from Clinical Trial Manager (CTM) or others
Develop and maintain effective and positive relationships with Investigators
Identify and escalate risks in study conduct and assist in mitigation, when appropriate
Collaborative and effective management of cross-functional study team activities as well as communication with and management of external vendors and stakeholders )e.g. CROs, IRBs/ECs and other external partners
Communicate trial status within and outside study team to ensure cross-functional alignment of expectations, priorities, and deliverables (enrollment, monitoring activities, site compliance and data metrics)
Anticipates, recognizes, and manages issues/risks and recognizes the need to seek assistance from or inform Senior Management
Implement clinical project plans in accordance with key study documents (e.g. Protocols, project plans and timelines, etc.) as well as corporate and regulatory objectives
Facilitate internal project team meetings
Other duties and responsibilities as required