| || The Clinical Study Manager will be responsible for implementing and executing Alcon’s clinical trials in the sites assigned under his responsibility. He should ensure compliance with international guidelines, local regulations and corporate policies and procedures
1.Successfully implements and executes Alcon’s phase I – IV clinical trials at their assigned sites
a.Ensures compliance with regulations, guidelines and policies for studies implemented at their assigned sites.
b.Supports budget and contract negotiation with investigational sites, as applicable, at their assigned sites; ensures payment for services.
c. Ensure recruitment strategies in place to meet study needs, including patient enrollment targets at their assigned sites.
d. Collaborates with Clinical Study Teams and within GCSM to identify and resolve site, quality or study execution issues.
2.Manage existing sites to meet Alcon’s projected patient recruitment needs in their region. Works with Regional Manager to:
-a.Monitor site quality and performance (metrics); develop solutions to optimize perfor-mance.
-b.Monitor site availability, commitments, infrastructure and capabilities.
-c.Ensure all safety issue are communicated and managed by Principal Investigator and study team in timelines appropriate to the regulatory and protocol requirements.
-d.Develop and implements effective corrective action plans for all quality issues identified at assigned sites.
-e.Actively participates with study team to stay current with study needs, communicating as needed with sites within defined timelines.
3.Maintain thorough knowledge of country regulations with special focus on regulatory requirements, guidance documents, and standards relating to global clinical trial conduct for medical devices, pharmaceuticals and biologics, and uses that knowledge to enhance site compliance and performance.
4.Performs all monitoring activities according to protocol monitoring plan and relevant WIs
- a.Maintain / demonstrate knowledge of the protocol, General Monitoring Guidelines (GMG), Protocol Monitoring Plan (PMP) and all protocol specific requirements
-b.Executes and maintains compliance with all established Alcon processes, procedures, and performance metrics.
-c.With support of Regional Manager, demonstrates flexibility to meet changes in work environment and study milestones with efficiency, and with strong communication and prioritization skills.
5.Builds positive relationship with principal investigators and site personnel under his responsibility.
| || • University degree in life sciences, Medical, pharmaceutical, biology, chemistry degree or RN preferred
•Fluency in both written and spoken Korean and English Minimum of 5 years operational experience_CRA in Pharmaceutical or Device company
-Basic Knowledge of applicable clinical research regulatory requirements; i.e, Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
-Effective time management skills
-Ability to manage competing priorities
-Ability to establish and maintain effective working relationships with coworkers, managers and clients
-Excellent verbal and written communication, problem solving skills and team orientation.