POSITION PURPOSE:

The Incumbent will serve as a clinical representative for assigned projects. In association with his/her immediate supervisor, manage the development and implementation process of Sigma-Tau’s services involving the Clinical Affairs department or cross-functional teams focused on the delivery of new or existing projects.  The Incumbent will monitor projects from concept through completion. (S)he will organize and coordinate the interdepartmental and outside vendor activities ensuring completion of the projects on schedule and within budget constraints to ensure success of the projects at all stages in the clinical process. The incumbent will also ensure compliance with applicable Sigma-Tau Standard Operating procedures and guidelines. 

DAILY RESPONSIBILITIES:
For assigned projects:

• In collaboration with department leads, manage the progress of clinical studies
• Assure clinical study conduct is in compliance with Sigma-Tau SOPs, Good Clinical Practice Guidelines and federal regulations governing the conduct of clinical studies
• Works with department leads to maintain projects within intended timelines and projected budgets
• Identifies issues affecting study conduct and work with department leads on satisfactory resolution
• Develops requests for proposal (RFP) and coordinates the selection of CROs and outside vendors

• Manages outside vendors and contractors

• Tracks  key project metrics and action items

• Tracks progress of all clinical study activities, including regulatory compliance, site selection, enrollment, site monitoring, drug supply, adverse events/serious adverse events, data management, biostatistics, and medical writing

• Assist with the development of study protocols

• Assist with the development of study timelines and budgets

• Track vendor and site payments Develops and/or coordinates the development of documents in support of clinical studies (CRFs, ICFs, manuals, etc)
• Work with internal departments and external vendors to establish appropriate study processes to ensure compliance with guidance’s and regulations.

• Reports progress of clinical projects to management Participate in the development, review and approval of vendor agreements and budgets

• Assesses training needs for Clinical Affairs project staff; conducts and documents training of team members
• Oversee study activities by Sigma-Tau staff, vendors, and contractors
• Supports site management and monitoring efforts as needed

• Monitoring of select sites to assure protocol & GCP compliance

• Participate in the development, review and maintenance of Clinical  Affairs SOPs

• Other duties as assigned 

SPECIFIC JOB KNOWLEDGE, SKILL AND ABILITY:

• RN or Bachelor’s degree within a health/biomedical sciences field, or related field and equivalent experience.

• 4+ yrs experience in clinical research with the monitoring and/or management of clinical studies in the pharmaceutical industry or at a CRO with experience in managing multi-center study set-up and execution.

• Knowledge of GCP, ICH guidelines and US FDA regulatory requirements for the conduct of clinical trials.
• Strong critical thinking skills.
• Strong ability to prioritize and organize workflow activities in a fast-paced environment.
• Proficient in basic computer programs such as MS Office Suite and MS Project.
• Excellent communication skills; ability to tactfully communicate sensitive information.
• Ability to work independently and in a cross-functional team environment.

• Must demonstrate excellent planning and organizational skills and an ability to generate creative solutions for complex problems.

• Basic understanding of clinical development, regulatory and QA, CMC, clinical trials operations and project management methodology.
• Ability to travel at least 20% of the time.