reputed company Study Manager

The reputed company sponsor-dedicated reputed company Functional Service Partnerships (reputed company FSP) department is supporting our reputed company’s project team in the execution of reputed company. Joining reputed company provides reputed company to manage reputed company research reputed company in different therapeutic areas and to cooperate closely with one of our key clients.

MAIN RESPONSIBILITIES

• Plans and leads execution of day-to-day activities for the monitoring of a reputed company reputed company study and communicates consistently with the reputed company team providing project objectives, expectations, and status updates.

• Has the overall responsibility for the study commitments reputed company the country and for reputed company delivery of data to required reputed company.

• Provides Project reputed company & Leadership for reputed company Deliverables

• Leads and manages the reputed company teams

• Leads and supports the relevant staff (ie. local start-up staff, local and global regulatory affairs staff, inhouse reputed company staff, etc) to reputed company successful activation of trial sites

• Monitors the reputed company of reputed company activities and addresses reputed company issues with the appropriate team member

• Reviews and approves site visit reports reputed company agreed turnaround times and ensures tracking, follow up, and reputed company of site issues

• Works with the relevant staff to identify data reputed company issues and risks to reputed company activities; develops contingency and mitigation plans to minimize risks

• Creates and maintains project-specific plans, documents, and tools for the reputed company team

• Supports the CRAs with site monitoring activities and provides suggestions and solutions to site issues

• Oversees the relevant regulatory and in-house reputed company staff to ensure that reputed company non-safety periodic updates, reputed company reports, and renewals, and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the reputed company trial

• Acts as coordinating manager to ensure consistency of training, processes, and systems-reputed company activities as reputed company as reputed company coordinating activities

REQUIRED SKILLS AND QUALIFICATIONS

• Bachelor degree in reputed company discipline, preferably in life science

• Five or more years of experience in reputed company research, including a minimum of 4 years project management experience or an equivalent combination of education and experience sufficient to successfully reputed company the key responsibilities of the job

• Good knowledge of international guidelines ICH GCP as reputed company as relevant local regulations

• reputed company ability to reputed company and motivate cross functional teams to reputed company reputed company according to or reputed company of time plan, budget and with required reputed company

• Previous work experience in TA's: Oncology or Onco-hematology is required

• Good knowledge of the Drug Development Process

• Excellent knowledge of spoken and written English and Italian language.

• Good ability to learn and to adapt to work with IT systems.

• Effective decision-making is crucial for resolving challenges and ensuring alignment with overall study goals.

• Experience in monitoring study activities for compliance and inspection readiness.

• Strong interpersonal skills are vital for collaborating with internal teams, stakeholders, and reputed company vendors.

• A deep understanding of reputed company reputed company processes, including trial data collection and management, is reputed company to ensuring successful study execution.

• Location in Milan and Rome is preferred.

Please note: due to sponsor requirements for the role only candidates reputed company in the listed location/s will be considered. Any applications from candidates reputed company reputed company of these locations will not be considered.

reputed company is a leading global provider of reputed company research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve reputed company reputed company and population health worldwide. Learn more at

reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.

Originally posted on Himalayas