Manage and co-ordinate early phase clinical study design and implementation at a program and functional level according to Good clinical practice (GCP) and Theravance Biopharma Standard Operating Procedures
Duties and Responsibilities
This position will provide leadership and support for early phase (1 through 2a) clinical studies at Theravance Biopharma.
The duties and responsibilities include but are not limited to the following:
• Responsible for operational input and oversight in designing, planning, initiating and completing phase 1 through 2a and clinical pharmacology clinical trials across a program(s).
• Expected to take the lead in writing clinical documents including study protocols, investigator’s brochures, and clinical study reports.
• Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program.
• Effectively lead the Clinical Operation Study Team(s) including in-house team members and those from Contract Research Organizations (CROs), vendors and other suppliers.
• Work with various in-house functional groups (including but not limited to Biometrics, Clinical Pharmacology, Drug Supply, Regulatory, Pharmacovigilence, Finance and Legal) with regards to operations issues of clinical studies including, for example, safety reporting and processing and study drug supply plans and monitoring.
• Manage the progress of clinical studies and ensure adherence to study protocols, regulatory and internal operating procedures, intended timelines and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and review and act on trending reports.
• Disseminate clinical project communications to appropriate functional groups
• Duties also may include participating in or leading cross functional initiatives aimed at developing or improving clinical operation process and standard operating procedures as needed under the guidance of the Director of Clinical Operation
• Position requires a minimum of a Bachelor of Science degree and at least 7 years of clinical study management experience, including at least 3 years of phase 1 study management experience (9 years of clinical management experience for Sr. Manager or graduate level education with at least 7 years of clinical study management experience) in clinical research within a pharmaceutical or biotech environment or relevant CRO experience.
• Experience working in therapeutic areas including cardiovascular, inflammation and general medicine a plus, or other indications including endocrinology, gastrointestinal disorders, and respiratory disease.
• Good understanding of clinical study implementation process.
• Strong understanding of CFR and ICH guidelines.
• Excellent oral and written communication skills
• Strong interpersonal skills.
• Strong Leadership skills.
• Ability to effectively work within a multidisciplinary team.
• Willingness to travel up to 30%, as necessary, consistent with study or functional needs.
This position does not have any direct reports at the present time but it is expected that this position will have the capabilities to take on supervisory responsibilities.
Regular working condition in office area. Full time schedule is expected.