SUMMARY

The role will include oversight and primary responsibility for designated clinical trials. The role will monitor and report on the progress of delegated clinical trials, as well as prepare, oversee, and review documents and study plans for the trial(s). The position will report directly to the Sr. Vice President and Head of Clinical Research and Development, or the Sr. Clinical Project Manager. This exciting opening offers the candidate the opportunity to be a part of a professional, customer-focused, pharmaceutical company with a competitive salary and full benefits package.

RESPONSIBILITIES

• Comprehensive oversight and execution of deliverables for assigned clinical trial(s).
• Prepare, oversee, and review documents that are related to assigned clinical study.
• Arrange or help in organizing clinical study meetings.
• Ensure the availability of necessary resources for the execution of clinical projects.
• Review and approve invoices being presented by study vendors and external consultants.
• Answerable to questions and issues raised by vendors and external consultants.
• Help in the training and development of clinical staff as needed.
• Lead the clinical project team and various study team meetings.
• Oversee the pattern and manner in which the assigned clinical research study is being conducted.
• Fully involved in resolving issues; take part in procedure improvement initiatives.
• Attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process.
• Coordinate with all functional teams within to ensure commitment to timeline and quality expectations, including Clinical Operations, Data Management, Medical Writing, Quality Assurance and Quality Control, Legal, Finance, and Senior Leadership, as well as external partners (CROs, Laboratories, Specialty service-providers, Investigators).
• Work hand-in-hand with clinical trial associates and document control personnel to manage documents that are related to the clinical study.

QUALIFICATIONS

• Bachelor’s and/or a Master’s degree in any science or health related field.
• 5 years’ experience in the field of clinical research of which 2 years must have been in a project lead role.
• Prior experience in one or more of the following therapeutic areas is preferred: Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis/Cirrhosis (PBC), Hepatitis, other Hepatic Disorders, GI Disorders, Diabetes, Metabolic Disorders, Lipid Studies, Cardiology and Oncology.
• Experience in writing clinical study procedures and other clinical documents is a plus.
• Must possess excellent communication skills to be able to effectively convey messages across to both study team members and other external partners such as vendors and external consultants.
• Good problem-solving, organizational, and leadership skills are highly required.
• Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects.
• Must be able to work as part of a team as well as lead by example.
• Ability to manage and motivate other members of the study team.
• Proficient user of basic computer applications for the execution of daily project operations.
• This position will require the candidate to have a willingness to travel (up to 15%)