Clinical Research Manager

2 weeks ago

Klang, Selangor, Malaysia Fortrea Full time

Essential Job Duties:


These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.


  • PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
  • MANAGEMENT: POC for assigned protocols.
Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated).

  • QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country.
Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor.

  • EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners.
Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.

  • INTERNAL COLLABORATION &

STRATEGY:
Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.

Experience:

Minimum Required:

  • Good organizational and time management skills
  • Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
  • Excellent communication skills, oral and written.
  • Selfmotivation with the ability to work under pressure to meet deadlines
  • Works well independently as well as in team environment.
  • Detail and process oriented
  • Positive attitude and approach
  • Interact with internal and external customers with high degree of professionalism and discretion
  • Multitasking capability.
  • Good computer skills with good working knowledge of a range of computer packages
  • Ability to lead and develop junior staff
  • Flexible and adaptable to a developing work environment
  • Minimum of sixeight (68) years of clinical research experience
Education/Qualifications

Minimum Required:

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
  • Thorough understanding of the drug development process
  • Fluent in local office language and in English, both written and verbal
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.

Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

For more information about Fortrea, visit

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply.

For more information about how we collect and store your personal data, please see our

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