BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Only Applicants with a valid work permit will be considered - we do not provide sponsorship for this position
General Description:
- Role will support the study team with Clinical Operations tasks, and/or assist in ensuring compliance including completeness and quality checks of the trial master file (TMF)
- Demonstrates basic clinical operations knowledge and strong organizational skills
- Implements best practices and shares lessons learned with team and other colleagues, as appropriate
- Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs
- The Junior Associate role in Clinical Operations is an entry level position
This job description provides the broadest description of potential assigned activities. There will be specific roles and responsibilities assigned from this Job Description, according to project assignment(s). As such, responsibilities will include some of the following activities, but may not be limited to:
Clinical Operations support to study teams:
Support cross-functional clinical study teams from start-up through close-out:
- Assists in development of clinical trial documents, manuals, trackers (may support informed consent development and version tracking)
- Preparation and documentation of internal and external meetings by preparing agendas and minutes
- Maintaining clinical operations tracking tools e.g.
- enrollment
- CTMS
- laboratory samples
- monitoring visits
- site status
- support in HA and IRB/EC submissions; support study team with site start-up preparation, EC fee application and tracking
- drug supply
- data cleaning
- vendor tracking
- training
- risk management
- study goals
- investigator contracts and payments; support study team with site level payments and invoices
- invoice reconciliation and budget tracking
- Support reporting for Senior Management updates
- Clinicaltrials.gov and/or local registry posting and maintenance
- Site materials and equipment: support study team with distribution of site materials and equipment, document printing, shipment, and other administrative work
- Administrative: business and department office administration support if required
Trial Master File (TMF)
- Support Clinical Operation Managers (COMs) with the setup, maintenance and close out of TMF.
- Coordinate document collection from others as appropriate.
- Upload documents to eTMF or other applicable document repositories ensuring quality documents are uploaded.
- Support TMF completeness activities.
- Follow TMF Plans, applicable SOPs, ICH/GCP guidelines and regulatory requirements.
- Support actions ensuring the TMF is submission/inspection ready
- Develop successful cross-functional relationships with internal and external TMF stakeholders
- Oversee documentation flow within projected timelines and determine course of action needed to prevent and remediate delays and errors with TMF compilation
- Support COMs in monitoring and reporting on progress of the TMF to stakeholders
- Apply lessons learned and demonstrate continuous improvement of documentation management practices across study teams
- Perform other TMF related tasks as needed.
Mentoring Responsibilities:
- More senior members of the associate team may mentor junior associates
- Associates with experience in specific tasks may mentor other associates with less or no experience in these tasks
Education Required:
- Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 2 years of experience in clinical operations (Senior Associate).
- Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* with minimum of 1 year of experience in clinical operations (Associate).
- Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline* (Junior Associate). Entry level.
- Exceptions may be made on case-by-case basis where candidates demonstrate appropriate skill set for a role in Clinical Operations and awareness of the role.
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoin