Local Study Manager
TFS, Italy
Job Description
TFS HealthScience is excited to be expanding our Strategic Resourcing Services team and we are looking for an experienced, highly motivated Clinical Research Manager (CRM) who shares our vision of providing clinical research excellence. Our Strategic Resourcing Services team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.
TFS HealthScience is looking for a Clinical Research Manager office based in Milan. We look forward to receiving your application!?
The Clinical Research Manager (CRM) is part of Site Management amp; Monitoring and will have the overall responsibility for managing projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations.
This role will sit embedded within one of our prestigious clients who promotes rapid career development.
Key Responsibilities:
- Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- Leads Local Study Team consisting of Clinical Research Associate, for assigned study/studies
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans
- Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
- Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
- Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and Procedural Documents.
Requirements
- Bachelor degree in related discipline, preferably in life science
- Minimum 4 years of experience as Clinical Team Lead, Clinical Project Manager
- Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
- Excellent project management skills.
- Excellent verbal and written communication skills in English and Italian
- Experience in Oncology is a plus
- Excellent team building and interpersonal skills
Benefits
Disclaimers:
What can we offer you??
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS HealthScience is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. Italy benefits include:?
- Competitive salary amp; benefits package?
- Excellent career progression opportunities?
- Great corporate culture and work life balance?
- Private Health Coverage
- Corporate Pension Plan
- Global General Liability Insurance
- Global Travel Insurance
- Internet costs are covered by TFS
- Flexible working schedule
TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the?privacy notice?for further details.?
TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.?