RWE Associate Site Manager - with Romanian or Portuguese or Dutch or Swedish or German or Spanish or Italian or French or Norweg
Complete appropriate therapeutic, protocol and clinical research training to perform job duties;
Gain experience with standard Quintiles tools, metrics and reports;
Develop an understanding of how sites are staffed and operate in order to build strong relationships with personnel at assigned sites;
Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology;
Under close supervision, may perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs and work instructions;
Under close supervision, administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues;
Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager;
Under close supervision, manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution;
Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines;
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint;
Strong written and verbal communication skills in applicable languages, level C1: Swedish or Dutch or Spanish or German or French or Italian, and level C1of English;
Basic organizational, interpersonal and problem-solving skills;
Strong attention to detail;
Working time management skills;
Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree or currently enrolled in bachelor's degree program preferably in life science; or equivalent combination of education, training and experience.
Extensive use of telephone and face to face communication requiring accurate perception of speech;
Extensive use of keyboard requiring repetitive motion of fingers;