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Job Details

Location
Salary
Permanent Role
Job Type
Permanent
Ref
BH-166569
Contact
Weiyan Woo
Posted
over 4 years ago
  • MNC Biotech Company located at CBD Area
  • Experiences in Clinical Research Organisations or Pharmaceutical Company
  • Experiences in Project Management is a MUST
Responsibilities: 
  • Responsible for planning, executing and successful completion of clinical research activities for clinical trials
  • Responsible for collating study metrics, developing and maintaining a comprehensive dashboard that is reported regularly to management and other stakeholders
  • Work collaboratively with other members of the Clinical Operations team and vendor partners to establish and maintain study timelines, develop and maintain study risk management plans, communication plans, project plans etc.
  • Ensure that clinical trials are conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, ICH guidance, and internal Standard Operating Procedures. 
  • Coordinate the completion of clinical and regulatory documents such as Clinical Trial protocols, Investigator Brochures, Clinical Trial Applications, etc. Write sections as directed. Perform and document quality review of these documents as needed
  • Conduct study operational feasibility and risk assessments, identify issues, summarize findings and recommend course of action or course corrections and mitigation plans, as appropriate. 
  • Work cross-functionally with other departments to forecast and maintain adequate clinical trial material or other study supplies
  • Work with other members of the Clinical Operations team to accomplish corporate, departmental and project-specific goals and help manage day-to-day study operations (e.g., site regulatory packet review, monitoring report review, review and tracking of invoices, data listing review, development of study-specific plans, etc.)
  • Ensure that proper study documentation is in place and that study issues are appropriately escalated to management, as needed
  • Ensure development of study specifications/scope of work/project timeline for Request for Proposal (RFP) development. Actively participate in bid defense, vendor selection and contract finalization meetings
  • Responsible for the management of Clinical Research Organizations (CROs), and other service providers, and serve as the primary liaison between the company and the external team members. 
  • Oversee planning of investigator meetings with vendor partners; participate in the presentation of operational information
  • Develop or review and provide feedback on all study plan documents including project management, safety management, monitoring, data management and statistical analysis plans
  • Manage vendors according to scope, budget and adherence to contract. Ensure any change orders are vetted with management and in place with the vendor prior to engaging in out-ofscope work
  • Assure proper study documentation is maintained and archived in the Trial Master Files. Periodically review eTMF and liaise with vendor partners to ensure inspection readiness. Work with vendor partners to properly document and archive files at study closure
  • Ensure that studies are entered and updated within required databases and registration systems such as Clinical Trials.gov
  • Manage post-market safety surveillance processes and requests for medical information, as necessary
Requirements:
  • BSc in scientific disciplines/life sciences (Pharmacology, Toxicology, Biology, Biochemistry, Physiology, Nursing, or closely related discipline
  • Minimum 5 years’ experience perform as project manager in a CRO/Pharmaceutical/biotech companies
  • More than 10 years’ experience in the biotechnology/pharmaceutical industry in clinical operations, clinical development or clinical project management disciplines
  • Strong knowledge of drug development and ICH/GCP guidelines
  • Knowledge of all aspects of clinical operations, from protocol concept through clinical study reporting etc.
  • Experience with multiple study phases (e.g., Phase I – IV) and IITs
  • Ability to work with a continued focus on quality, efficiency and ongoing improvement through decision making, planning and organizational skills, communication and quality orientation
  • Proven interpersonal, written and verbal communication and organizational skills
  • Proven ability as an effective leader (e.g. training, decision-making, problem-solving,negotiating etc.)
  • Commitment to teamwork
  • Ability to work in ambiguous situations and make appropriate course corrections
  • Ability to utilize various electronic systems and software- intermediate computer skills required. 
  • Facility with MS Office applications is a must, particularly Excel, and familiarity with MS Project are preferred. 
  • Ability to travel as needed for investigator meetings, vendor auditing and oversight, internal team meetings etc. 
Interested candidates can forward their CVs in MS Word format to weiyan@connect-ebc.com

Reg No. R1983718
EBC Connect Pte Ltd
Licence no. 17C8975