CRA Manager

Petaling Jaya, Selangor
Tetap
Sepenuh masa

1 bulan lepas

Job DescriptionThis role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP.As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance.The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities. The role will collaborate with country PLMs to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.Responsibilities include, but are not limited to:

Work allocation, staff development and performance appraisal.

Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.

Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.

Attend local Investigator Meetings if requested to.

Interface with GCTO partners on clinical trial execution.

Escalates site performance issues to CRM and Clinical Research Director CRD.

People and Resource Management:

o Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.o Support and resolve escalation of issues from CRAs.o Liaise with local HR and finance functions as required.o Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.o Provides training, support and mentoring to the CRA to ensure continuous development.o Ensures CRA compliance to corporate policies, procedures and quality standardsCORE Competency Expectations:

Ability to work independently and in a team environment

Excellent people management, time management, project management and organizational skills

History of strong performance

Skills and judgment required to be a good steward/decision maker for the company

Fluent in Local Language and business proficient in English (verbal and written)

Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines

Expertise in and excellent working knowledge of core trial management systems and tools

Behavioural Competency Expectations:

High emotional intelligence

Strong leadership skills with proven success in people management

Excellent interpersonal and communication skills, conflict management

Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators)

Influencing skills

Experience Requirements:Required:

Minimum of 5 years´ experience within Clinical Research

Minimum of 3 years’ experience as CRA monitoring clinical trials

Line management experience preferred or at the minimum team leader experience

Educational Requirements:Required:

Bachelor’s degree in Science

Preferred:

Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology

HYBRID WORKING- Must travel Singapore/ Malaysia up to 50 %SINGAPORE-MALAYSIA COVERAGERequired Skills: Adaptability, Biological Sciences, Clinical Research, Clinical Research Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Management Processes, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Decision Making, Ethical Standards, Good Clinical Practice (GCP), Immunochemistry, Oncology Trials, People Leadership, People Management, Project Management, Resource Allocation, Resource Planning, Stakeholder ManagementPreferred Skills:Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 03/31/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

MSD

Memohon