LSKB is hiring a Global Clinical Project Manager
Position Summary:
This position functions as a Clinical Project Manager for global late stage clinical trials within LSK BioPharma (South San Francisco) or within LSK Global CRO (Seoul) as the relevant study/project requires. The Global Clinical Trials Manager (GCTM) works primarily with CRO and other vendors and with various internal team members to ensure that CRO are compliant and that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. This position may be responsible for ensuring achievement of own or others project goals and objectives.
Other Potential Duties & Responsibilities:
- Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
- Work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
- Manage Clinical Operations personnel within CRO and internally
- Oversee CRO activity including but not limited to the clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
- Serve as a liaison and resource for CROs
- Manage the operational aspects of clinical trials
- Manage the study project plan, including timeline, budget, and resources
- Participate in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriate
- Prepare metrics and updates for management, as assigned
- Proactively identify potential study issues/risks and recommend/implement solutions
- Participate in and facilitates CRO/vendor selection process for outsourced activities
- Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
- Participate in the development, review and implementation of departmental SOPs and processes
- Recommend and implement innovative process ideas to impact clinical trials management
- Organize and manage internal team meetings, investigator meetings and other trial-specific meetings
- Review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
- Participate in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
- Perform other duties as assigned
Experience and Education Required:
- A 4-year degree from a university in a Life Science preferred
- 8+ years of related clinical trial management experience with a minimum of 2 year of supervisory experience preferred (experience must be commensurate with the scope of work that the contractor is supporting and thus may be less than noted above)
- 4+ years of experience in interactions with outside vendors, e.g., CROs and other vendors
- Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
- Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
- Able to deal with time demands, incomplete information or unexpected events
- Able to provide clinical operations expertise to clinical development in a specified product area or project
- Able to travel approximately 10% overnight (50% or greater during peak times) including international travel
- Bilingual in Korean/English preferred
Behavioral Competencies Required:
Must possess excellent interpersonal skills. Must have the ability to build and maintain positive relationships with management, peers, and subordinates. Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail required.
Supervisory Responsibilities:
Carries out supervisory responsibilities in accordance with the organization policies and applicable laws. Responsibilities may include planning, assigning, and directing work. This position may also supervise work in a matrix organization.
Physical Demands Required:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or abilities required. The employee may frequently be performing repetitive movements such as typing on a keypad or using a mouse. The employee may occasionally climb or balance, stoop, kneel, or crouch. The employee must on occasion lift and/or move up to 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Send resumes to angieprice@lskbiopharma.com
