Clinical Project Manager II / Senior Clinical Project Manager

United Therapeutics Corporation•RTP, NC, NC

5d•Hybrid

About The Position

United Therapeutics (Nasdaq: UTHR) is a public benefit corporation dedicated to developing novel pharmaceutical therapies and technologies for organ transplantation. Founded in 1996, the company has developed six FDA-approved therapies for rare diseases like pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma. United Therapeutics is also working on creating manufactured organs to address the shortage of transplantable organs. This role involves leading clinical studies that aim to redefine patient treatment options. The position offers autonomy in driving studies, support from cross-functional teams, and exposure to cutting-edge science. The company culture emphasizes purpose, innovation, determination, and a belief that work can be both meaningful and enjoyable. The ideal candidate is a proactive problem-solver who thrives on ownership, collaboration, and making a real impact.

Requirements

Bachelor’s degree in related field and 8+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development (for Clinical Project Manager II level)
Master’s degree in related field and 6+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development (for Clinical Project Manager II level)
Bachelor’s degree in related field and 10+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development (for Senior Clinical Project Manager level)
Master’s degree in related field and 8+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development (for Senior Clinical Project Manager level)
Ability to interact and communicate effectively, both verbally and in writing, within and outside clinical operations, with colleagues, upper management, Key Opinion Leaders, vendor personnel, and clinical investigators and site personnel.
Strong working knowledge of GCP/ICH regulations and guidelines.
Strong overall scientific and clinical/medical research background.
Experience and comfort in working both independently and as part of a cross-functional team.
Proficiency with MS Office Suite including Word, Excel, PowerPoint, and Outlook.
Experience with EDC and CTMS systems.
Commitment and ability to handle high workloads, demanding situations, and deadlines.
Ability to proactively identify potential issues and formulate potential course(s) of action.

Nice To Haves

Master’s degree
3+ years of related experience as a CRA, Clinical Manager, and/or Project Manager in the biopharmaceutical industry highly preferred
RN - Registered Nurse - State Licensure and/or Compact State Licensure
Previous experience with all phases of clinical research
Demonstrated leadership experience as evidenced by the ability to motivate teams, provide advanced planning analysis, provide strategic guidance by evaluating risks against departmental deliverables

Responsibilities

Work independently to ensure the success of a local or regional clinical trial.
Provide oversight and coordination for the operational delivery of ongoing local or regional clinical trials to ensure all required timelines are met as well as adherence to budget, quality, and performance expectations.
Utilize advanced expertise and serve as the primary study contact for study-related communication, coordinating with teams, management, and vendors.
Independently oversee the entire lifecycle of clinical trials, from start-up to close-out.
Direct local or regional clinical trials, ensuring cross-functional activities align with study objectives.
Administer study budgets and timelines, maintaining high-quality standards and performance metrics.
Identify, resolve, or escalate any concerns regarding study timelines and deliverables promptly.
Proactively escalate performance related concerns with appropriate line management.
Manage protocol deviations/violations diligently, reducing their occurrence through proactive collaboration.
Collaborate with Clinical Operations to monitor key performance indicators, enhancing study efficiency.
Provide consistent updates on study progress to the project team and management.
Manage insourcing / outsourcing partners, ensuring compliance with standards and expectations.
Contribute to the development of study concepts, protocols, and critical study documents.
Engage in the creation of policies, guidelines, and SOPs, contributing to the advancement of Clinical Operations and Study Management.
Assess and enhance current processes, recommending improvements to management.
Ensure study conduct aligns with SOPs, ICH/GCP guidelines, and local regulations.
Manage vendor relationships, including selection, negotiation, implementation, and statement of work (SOW) oversight.
Ensure comprehensive protocol and process training for all study team members.
Manage resources allocated to the study, excluding staff management.
Review and endorse team member transition plans as necessary.
Assist in the preparation of interim and primary analysis reports.
Organize and oversee Investigator Meetings, ensuring effective coordination.
Perform all other duties as required.