Parexel
Clinical Trial Manager - Remote – FSP
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Parexel
Parexel is seeking a Global Clinical Trial Manager (CTM) to join our Development Operations team in Italy, dedicated to a single sponsor. You will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group. The role offers long‑term job security with opportunities to work on vital studies for global biotechs and top pharma.
Responsibilities
Manage external vendors and contract research organizations.
Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual.
Coordinate design of study materials: CRFs, patient diaries, study participation cards, source documents.
Assist with protocol development and study report completion.
Manage monitoring activities, including routine on‑site clinical monitoring, ensuring adherence to GCP, SOPs, and protocols.
Provide guidance, direction and management to CRAs.
Track patient enrollment; qualify, initiate, monitor, closeout activities and review site reports; assist in data management coordination.
Coordinate study supplies.
Negotiate contracts with vendors of clinical trial services.
Requirements
Bachelor’s degree or nursing degree (science preferred).
5+ years of industry experience in global clinical studies (pharma, biotech, CRO).
Proven track record as a CRA in the pharmaceutical industry.
Experience managing clinical trials, including CNS and/or oncology (preferred).
Leadership experience in a matrixed environment.
Global clinical trial management experience.
Knowledge of GCP, ICH guidelines, FDA regulations.
Ability to work independently and as part of a team.
Travel required: 15‑25%, including international.
Proficiency with MS Office (Word, Excel, PowerPoint, Outlook).
Excellent oral and written communication and strong organizational skills.
Additional Information We care about our people and offer a friendly work environment with opportunities for long‑term career development. This is a full‑time position. Seniority level: Mid‑Senior.
Employment type: Full‑time. Job function: Health Care Provider, Science, and Research. Industries: Pharmaceutical Manufacturing, Biotechnology Research, Hospitals and Health Care.
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at
Parexel
Parexel is seeking a Global Clinical Trial Manager (CTM) to join our Development Operations team in Italy, dedicated to a single sponsor. You will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group. The role offers long‑term job security with opportunities to work on vital studies for global biotechs and top pharma.
Responsibilities
Manage external vendors and contract research organizations.
Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual.
Coordinate design of study materials: CRFs, patient diaries, study participation cards, source documents.
Assist with protocol development and study report completion.
Manage monitoring activities, including routine on‑site clinical monitoring, ensuring adherence to GCP, SOPs, and protocols.
Provide guidance, direction and management to CRAs.
Track patient enrollment; qualify, initiate, monitor, closeout activities and review site reports; assist in data management coordination.
Coordinate study supplies.
Negotiate contracts with vendors of clinical trial services.
Requirements
Bachelor’s degree or nursing degree (science preferred).
5+ years of industry experience in global clinical studies (pharma, biotech, CRO).
Proven track record as a CRA in the pharmaceutical industry.
Experience managing clinical trials, including CNS and/or oncology (preferred).
Leadership experience in a matrixed environment.
Global clinical trial management experience.
Knowledge of GCP, ICH guidelines, FDA regulations.
Ability to work independently and as part of a team.
Travel required: 15‑25%, including international.
Proficiency with MS Office (Word, Excel, PowerPoint, Outlook).
Excellent oral and written communication and strong organizational skills.
Additional Information We care about our people and offer a friendly work environment with opportunities for long‑term career development. This is a full‑time position. Seniority level: Mid‑Senior.
Employment type: Full‑time. Job function: Health Care Provider, Science, and Research. Industries: Pharmaceutical Manufacturing, Biotechnology Research, Hospitals and Health Care.
#J-18808-Ljbffr