Study Manager

Basic qualifications:

Bachelors degree in clinical medicine or a life/biological science

At Least 4.5 years clinical operation experience in the top pharmaceutical or CRO

Familiar with Good Clinical Practice and relevant local regulations

Excellent command of spoken and written English and able to read it accurately

Good computer skills including proficiency with Microsoft Word, Powerpoint, Explorer and

Outlook and familiarity with the internet

Excellent communicator both verbally and through the written word

Well-organised

Effective time-management skills

Good team-work skills

Good presentation skills

Ability to manage competing priorities

Good problem-solving skills

Good negotiation skills

Good interpersonal skills

Experience working as a Associate Study Manager for at least 1.5 years

Preferred qualifications:

RECRUITER TO UPDATE

Details:

Lead study level feasibility conduction to time and quality; Provide competitive proposal on patient target and cost in consideration of local medical practice and business needs; Final decision maker for site selection by balancing both business and quality study needs through cross function work

Track, oversee and manage to agreed study timelines, budget and resource; highlight significant

variances and risks and take appropriate actions to get study on track

Identify resource need and secure resources from various departments, timely form a motivated and aligned study team that delivers the study results on or ahead of time and to high quality

Set-up and maintenance of all systems, track and manage to agreed study timelines, budget, and resource

Ensure clinical supply met study conduction demands to quality and timely

Develop recruitment strategy, manage risk (mitigation and contigency plans), monitor progress and well execute and follow-up

Responsible for study quality; Work with CRA manager and QC to develop and implement study QC& co-monitoring plan; review monitoring visit reports in a timely manner, ensure the reports reflected activities, communication and findings at site, avoid repeated findings

Lead and approve study document generation, translation and finalization; Review and approve study agreements and study payment reports; Obtain and maintain essential documentation in compliance with ICH GCP, SOPs and local regulations at Investigator sites and sponsor offices

Responsible for investigator and monitor meeting preparation, execution, and follow-up

Drives assessment, selection, engagement, training and management of appropriate vendors for outsourced clinical activities/services and ensures compliance with GSK standards, GCP, regulations and CSP

Ensures monitor and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented

Develops a study communication plan to ensure efficient and appropriate communications with all internal and external stakeholders

Identifies quality issues within the study and implements appropriate corrective action plans.

Escalates findings and action plans to appropriate parties

Continiously support CRA competency development through mentoring, training, team support and performance feedback

Share and drive best practice with team members; Attend and actively contribute to meetings and trainings

Act as CRA to deliver a clinical study at site to time, quality and budget in compliance with

GCP/SOPs, local regulations and the Clinical Study Protocol from site selection and CSR

signature/site closure

Perform other tasks assigned by line manager

Contact information:

You may apply for this position online by selecting the Apply now button.

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