||Monitors activities conducted by clinical investigative sites as they relate to clinical studies to ensure successful execution of the protocol. This position function in an off-site and affiliate based capacity.
The Associate Clinical Operations Manager（ACOM） conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring studies are conducted accoring to all applicable regulations and business processes. Ensure regulatory inspection readiness at assigned clinical sites. May be responsible for assignments of greater complexity than the Clinical Research Associate(i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues).
Additionally, the ACOM may trrain and provide guidance to junior staff.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Supports the Clinical Operations Manager (COM) and/or Senior Clinical Operations Manager (SrCOM) in the provision of leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management &Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US)/ region (US) of responsibility.
In the country/region based, may manage up to 6 SCRAs responsible for site identification, qualification,initiation, interim monitoring and study close-out visits for Phase 1-4 studies.
Gives support in providing ongoing assessment of resource needs and in allocating resources in alignment with Our research goals, priorities and specific study timelines. Identifies and communicates issues that impact resource allocation and provides solutions.
・MS, MA, MBA, MPH desired
・Minimum of 5 years clinical related experience, with a minimum of 2 years as clinical research monitor.
・Experince in on-site monitoring of investigational drug in multi-therapeutic areas desired.
・Expert knowledge and understanding or appropriate therapeutic indications as they relate to the conduct of clinical trials.
・Expert knowledge of regulations governing clinical research, ICH/GCP Guidlines and applicable regulations.
・Proven strong site management and monitoring skills.
・Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
・Current in-depth knowledge and understanding of appropriate therapeutic indigations as they relate to the conduct of clinical trials.
・Good negotiating skills, tact and diplomacy.
・Storong ability to work independently in a geographic region with minimal superbision.
・Working knowledge and high experience with electoric data capture systems and clinical trials management systems.
・Proficiency in the use of personal computers, including experiences with word processing, spread sheets, email and web-browser applications.
・Excellent communication and interpersonal skills, including situations of conflict resolution, problem solving and crisis management. Demonstrated proactive and positive team player.
・Exhibits high level of flexibility when facing changes in the work environment.
・Acute observational skills, analytical and conceptual capabilities.
・Strong ability to work independently in a geographic region with minimal supervision.