CRA Manager

MSD

Taipei City
Permanent
Full-time

1 month ago

Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

This 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 6-14CRAs and to ensure excellent studyand siteperformance 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 CRAsand 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, PLMSand 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 siteor CRAoperational 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:

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

CORE 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 12 years´ experience within Clinical Research

Minimum of 5 years’ experience as CRA monitoring clinical trials

At least 2 years of people management experiences.

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 biologyWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.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: DomesticVISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):

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