Position description:

This role will assist Clinical Project Managers/Clinical Director in the design, planning, implementation and monitoring of clinical studies. Ensures studies are conducted, recorded and reported in accordance with the clinical protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements.

Oversight and Execution Responsibilities:

• This role will assist Clinical Project Managers/Clinical Director in the design, planning, implementation and monitoring of clinical studies. Ensures studies are conducted, recorded and reported in accordance with the clinical protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements.
• Independently conduct monitoring visits at investigational sites, including site qualification, initiation, progress and close-out visits. Prepare and submit monitoring visit reports in accordance with Durata's SOPs.
• Train investigational site personnel to the clinical protocol and industry standards including ICH-GCP.
• Verify study data on source documentation and case report forms to ensure compliance with the study protocol. Identify and resolve data discrepancies.
• Assist in the preparation of study documents including, but not limited to, clinical protocols and amendments, case report forms, informed consent forms, site training materials and clinical study reports.
• Obtain, collate and file essential clinical documents in accordance with Durata’s SOPs.
• Other duties as assigned

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelor's degree or equivalent experience in relevant field (science, nursing, medical or pharmacy degree preferred)
• 2-3+ years of experience in managing, training and mentoring of other CRAs
• Knowledge of applicable standards, regulations and ICH-GCP for clinical study conduct
• Excellent oral and written communication skills
• Confident and influential approach
• Understanding of the needs of others
• Experience of coordinating and planning budgets, people and time management
• Excellent planning, organizing, interpersonal and leadership skills
• Demonstrated experience in computer skills including Microsoft Word, Excel, and basic templates

Personal attributes will include:

• Making independent choices and to take responsibility for own actions
• Recognizing potential obstacles and working to resolve them within set timelines
• Being conscientious and precise in delivery of work even when under pressure
• Being collaborative and team oriented
• Willingness to travel up to 75% of time

About Durata Therapeutics

Durata Therapeutics is an equal opportunity employer welcoming diversity in our workforce.

Durata Therapeutics is a biopharmaceutical company addressing the growing need for new therapeutics to treat infectious diseases. Durata's current late-stage clinical product, dalbavancin, is a next-generation lipoglycopeptide with unique features, including convenient, once-a-week dosing. To date, dalbavancin has been shown to be effective and well-tolerated in late-stage clinical trials of patients with skin infections, supported by a promising safety profile based on clinical data in over 1300 patients. The Company also has two antibiotic programs in earlier-stage, preclinical research.

Durata's senior leadership has substantial experience at leading healthcare companies, including in medical affairs, operations and manufacturing and with multiple U.S. and global product launches. Durata is supported by a premier team of venture capital organizations, including New Leaf Venture Partners, LLC, Domain Associates, LLC, Aisling Capital, Sofinnova Ventures Inc. and Canaan Partners.