Shire Sr Clinical Project Manager - Real World Late Phase Studies in Zug, Switzerland
Registry Manager is responsible for managing or supporting the management of Registry Outcome Surveys conducted within the Global Clinical development Group. This individual may lead cross functional team members to appropriate and timely completion of registry-related projects; may oversee project timeline development and maintenance. Internally interfaces with data management and biostatistics, CRO’s, CRAs, and will be a liaison with investigators and clinical site staff.
Candidate will have experience in managing some aspects of Registry outcomes from start-up to close-out activities to assure adherence to intended timeline to achieve survey goals while ensuring compliance in accordance with FDA, EMA, GCP, and ICH guidelines.
Candidate will have experience in coordinating interdisciplinary activities involving study/site start-up: investigator meeting planning, case report form development, informed consent development, development of contracts and budgets and study manuals
Together with the Registry Lead, create and implement a strategy for the registry
Candidate will support Registry Lead in activities to ensure Global Regulatory Objectives/Commitments are properly prioritized.
Oversee contract organizations to help in the execution of the Registries. Contribute with the selection and management of contractors and third parties for work conducted by Shire Outcome Survey group and ensure successful conduct of Outcome Surveys by managing daily activities including timelines to ensure data integrity and quality
In close relationship with the CRO and OS Data Manager, ensure high quality and completeness of the data.
May Plan and implement resource allocations (both people and financial) to the individual surveys and activities of the department in collaboration with the Registry Outcomes Team Lead or Registry Lead. Assuring effective resource utilization in line with the department priorities
Work with marketing and commercial colleagues on strategies for supporting products during their life cycle, identifying research to support sales and ensuring its execution
Education and Experience
Scientific/health care field preferred but not required.
A background with demonstrated success in clinical project management in the pharmaceutical industry
Experience managing GCP studies (both clinical and post-market)
Experience with observational databases preferred
Strong Organizational, IT and writing skills, as well as strong attention to detail
Experience in building relationships with physicians/centers, in particular KOLs
Experience in managing external expert groups
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.