: Clinical project team member: works closely with the Sr. CTM and/or Clinical Program Manager and is responsible for oversight..., coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development. Responsibilities...
Job Description Role Summary: The Senior Clinical Project Manager leads and manages complex clinical studies... are delivered on time, within budget, and in compliance with GCP, ICH, and FDA regulations. The Senior Clinical Project Manager...
environment to ensure the successful development of new drugs. Responsibilities: Review clinical trial protocols... Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid...
oral and written communication skills. Must have knowledge of clinical safety and clinical trial management systems (e.g... CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs...
er submission planning; support of submission activities for initial INDs, NDAs, amendments/supplements, Clinical Trial... clinical trial applications. Coordinates with Regulatory operations for submission planning of new applications, supplements...
to join our Metro Regional Office. This role will provide clinical assessment and evaluation at the request of the Regional Director... and other specialized clinical assessments and evaluations. The Intake and Eligibility Psychologist will also maintain a current working...
and execute communication plans for significant pipeline milestones, including clinical trial initiations, data readouts..., compliant, and timely communications regarding clinical trial progress, results, and implications for patients and partners...
and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its... environments. Director- or Senior Manager-level leadership experience required, with direct people management responsibility...