Senior Manager, Medical Research Operations (BB-095CB)
Found in: Neuvoo HK
This position is responsible for supporting the research operations of the Biogen Asia-Pacific (APAC) Medical Affairs team. The Sr. Manager will work closely with the managers of Medical Affairs and Operations of every APAC affiliate to plan, launch, and manage research projects intended to produce scientific data in the disease areas of interest to Biogen. The position reports to the Director of Medical Research Operations Study Management.
The Sr. Manager will be responsible for coordinating all assigned Medical Affairs activities surrounding data generation, analysis, and results reporting. Tasks include developing and updating applicable local affiliate SOPs, aligning local SOPs with global SOPs, facilitation of research protocol creation by appropriate medical research experts, leading feasibility assessments, and oversight of the conduct of Phase 4 studies, patient registry programs, and real-world evidence (RWE) generation. S/he also will be responsible for coordinating robust analysis of data from post-marketing studies as well as post-marketing surveillance programs. All activities will be documented and updated in the Biogen Medical Affairs Research System (MARS) used to track medical research projects.
- Oversight and Co-ordination of Research Agreements and Projects across the APAC region.
- Liaise with global departments to ensure all current active studies are appropriately documented and reported in the MARS system.
- Partner with regional and affiliate medical teams to develop regional / affiliate level data generation strategy
- Work closely with Medical Research Experts, Medical Managers, and other stakeholders to coordinate the development of study protocols
- Coordinate procurement and oversee vendor contracts for all post-marketing research activities
- Coordinate between external customers, finance teams, Medical Science Liaisons (MSL) and Medical Managers to ensure invoicing/payment is appropriately tracked and documented in accordance with procedures and contract milestones.
- Provide ongoing documentation of study tracking and progress on a regular basis
- Interact with external research partners at study/trial sites to facilitate study progress and ensure appropriate procedures and processes are followed.
- Coordinate with internal Biogen process, infrastructure, and compliance colleagues to ensure appropriate local SOPs related to data generation, analysis, and dissemination are available and up to date. Align local SOPs with all global SOPs as applicable
- Plan and execute appropriate training/re-training of the Medical teams on these SOPs
- Co-ordination of patient registry activities in collaboration with Medical Managers
- Oversee and manage patient registry program operations.
- Collaborate with medical managers and other department stakeholders in the ongoing refinement of RWE data generation strategy.
- Facilitate the evaluation and sourcing of external data/real world evidence to support Biogen APAC Medical activities and research partners
- Data Analysis and Publications Planning:
- Coordinate with Global Medical and vendor data management and statistician colleagues in order to ensure delivery and accuracy of data analysis for local study protocols
- Participate in publication planning and road mapping in collaboration with Medical Managers and Biogen publication team
- Able to identify problems, conduct analysis, create solutions and communicate to stakeholders
- Able to provide proactive input on business issues
- Able to make evidence-based decisions in the best interests of the research program
- Strong Project Management skills including risk assessment and contingency planning
- Demonstrated ability to mentor / manage people
- High degree of learning agility
- Combination of critical thinking and operational know-how
- Demonstrated success in working independent
- High level of customer orientation awareness and focus
- Strong preference for experience with late phase and observational clinical research
- Neuroscience or rare disease experience preferred
- Exceptional analytical, problem-solving, and troubleshooting abilities
- Strong written and verbal communication skills
- Fluency in English required; Chinese (Mandarin) a plus
calendar_today4 days ago
location_on Hong Kong