Clinical Trial Junior Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7x3154

Location : Padova (PD), Italy Reports to : Tommaso Leonardi Time : Full-time Expectations for All Employees: Supports the organization's missions, vision and values by exhibiting the following behaviors; excellence and competence, collaboration, innovation, respect, personalization, commitment to our community, and accountability and ownership Position Summary: Assists with coordination of CTNI-managed clinical trials, the hire is from an EOB (Employer on Behalf) Competencies Required:
Excellent communication skills
Sound interpersonal skills and the ability to supervise others
Ability to work independently and display initiative to introduce innovations to research study
Ability to prepare/monitor budgets
Ability to identify problems and develop solutions
Ability to prioritize tasks and set deadlines Primary Duties as Junior Project Manager of a Clinical Trial: Schedule interviews with sites Obtain interview results from doctors, track results, and communicate results to sites and sponsors Manage Rater Training using Excel, MGH LMS and Red Cap Manages creation of study deliverables, including SAFER Implementation Plan, Rater Training Plan, etc. Organize and attend conference calls and distribute minutes accordingly Attend Investigator and Sponsor Meetings as necessary Submit study protocols, protocol amendments, and study staff certifications to the IRB Coordinate and respond to audits by study sponsors Other Tasks, As
Required:
Verifies accuracy of study forms
Updates study forms per protocol
Prepares data for analysis and data entry
Assists with formal audits of data
Assists with study regulatory submissions
Verifies subject inclusion/exclusion criteria
Maintains research data, patient files, regulatory binders and study databases




Performs data analysis and QA/QC data checks
May develop systems for QA/QC
Acts as study resource for sites
Monitors and evaluates lab and procedure data
Prepares for FDA and IRB annual reviews
Recommends protocol changes and may assist with writing protocols and manuscripts
Works with PI to prepare complete study reports
Responsible for quality control
Designs research protocols in conjunction with PI
Assists in the selection of study sites
Tracks and analyzes trends across studies, study sites, and CTNI clinicians
Invoices sponsors and processes payments to vendors
Orders supplies, handles computer and telephone issues, and communicates with property management
Participates in regular meetings with operations and clinical teams
Facilitates any rater communication with study sites as requested
Creates/distributes study reminders
Acts as general resource for study information Requirements: Bachelor degree required. Appreciated a 1-3 years of work experience/clinical experience Must be knowledgeable about computers and data management systems and familiar with common software packages (Word, Excel, Power Point, Access, Outlook) and Internet communication Familiarity with statistical packages (SPSS, SAS) desirable Must have the capability of prioritizing multiple competing tasks and seek supervisory or administrative assistance when appropriate Work Schedule (flexible): Monday through Friday, 9:00 to 18:30 or 18 (depending on lunch break choice) Working Relationships: Must be able to communicate in English well both verbally and in writing with internal and external clients Salary : negotiable RAL, spending on experience and previous qualifications. The base salary shall start from ****** Euro per year. Deadline for Application: September 15th ****

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7x3154