Job description
Job Title: Associate Manager, Clinical Operations Site Management - Italy/Spain/Serbia-
Job Location: Rome, Italy
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What Clinical Operations Site Management does at Worldwide
Embark on a fulfilling Clinical Operations career as you leave a lasting impact on patients’ lives. Join Worldwide Clinical Trials for an unparalleled CRO experience, where you can drive extraordinary scientific breakthroughs and contribute to the very heart of every successful clinical trial.
Working alongside brilliant minds across a variety of therapeutic areas, you will have the chance to collaborate closely with top-tier colleagues from diverse backgrounds and specialties. Our commitment to advancing clinical research is cultivated in a supportive, team-oriented atmosphere, with our hands-on leadership and dedicated team members working together to innovate and solve complex challenges for our customers.
What you will do
Responsible for interviewing and selecting CRA/IHCRA candidates and ensuring consistent onboarding of permanent and contract CRAs/IHCRAs
Ensure CRAs are properly and timely trained to perform all types of visits as well as other billable monitoring activities
Provide on-site mentoring for CRAs through observation or site assessment visits
Establish regular communication and1:1 calls with CRAs/IHCRAs to review and discuss quality metrics (SVR compliance, SDV metrics, TMF readiness, expense report submissions, project status, etc.)
Act as point of escalation for CRA/IHCRA performance issues on projects
Review Time Cards, including review and approval of hours billed by contractors
Review the accuracy of Sciforma assignments and workload
Conduct performance appraisals, rewarding and disciplining employees, addressing employee relations issues and resolving problems
Write and conduct CAPAs when necessary; Support Directors of Clinical Operations
Approve CRA/IHCRA PTO requests
Review and approve CRAs/IHCRAs' non-billable expenses
What you will bring to the role
Ability to understand multiple study protocols.
Superior oral and written communication skills.
Strong planning and organizational skills.
Good interpersonal skills.
Experienced problem solving/decision making skills.
Good attention to detail.
Understanding of clinical research principles and process, data collection and editing skills.
Ability to navigate in EDC software (InForm, Medidata, etc.)
Strong knowledge of FDA regulations, ICH Guidelines and HIPAA.
Understanding of standard operating procedures.
Knowledge of therapeutic areas.
Knowledge of Word, Excel and Outlook
Your Background
Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and six years clinical research experience as a clinical research associate OR
Two-year college curriculum (unless nursing degree then see requirement above) or equivalent education/training and seven years clinical research experience as a clinical research associate OR
Eight years of clinical research experience as a clinical research associate or other position directly related to clinical research with a pharmaceutical or biotechnology company
Travel required/Valid passport required
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.