Discover the Exciting Role of a Clinical Research Manager – LifeScience Clinical Research Jobs
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. LifeScience Clinical Research Jobs.
Job role – Clinical Research Manager
Location – Selangor, Malaysia
Essential Job 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 the 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 works on training needs in collaboration with a functional vendor.
EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, and 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: LifeScience Clinical Research Jobs
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 an operational project team and investigative sites preferred
- Excellent communication skills, oral and written
- Self-motivation with the ability to work under pressure to meet deadlines
- Works well independently as well as in a team environment
- Detail and process-oriented
- Positive attitude and approach
- Interact with internal and external customers with a high degree of professionalism and discretion
- Multi-tasking 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 six-eight (6-8) 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
- In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a healthcare setting will be considered
- 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 the local office language and in English, both written and verbal
