Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Sr. Medical Research Project Manager
Your tasks and responsibilities
- Supervises PAC studies from technical support and expertise.
- Oversight PAC studies from compliance and quality.
- Oversight the process and delivery, ensure fulfill regulatory requirement.
- Supervise and provide technical support project manager.
- Perform project quality control and local SOP development and initiative process improvement in the team.
- Develop appropriate project QC plan to SO run studies and perform accordingly. Detect and diagnose the issues, risks, especially systematic problems, oversight the CAPA.
- Joining global platform representing China SO, such as GNIS community. Contribute in the platform and bring back good experience into local projects.
- Develop local SOP per local needs and global SOP.
- Well support in corporate and system audit, clearly present the process during the audit.
- Provide training, finding sharing to the team.
- Initiative process improvement in the team, enhance the quality and effectiveness.
- Manage complex company sponsored study
- Ensuring assigned post-marketing studies implementation in accordance with protocol, SOPs and timeline, throughout the whole process of trial, for example but not limited; investigator meeting, trial initiation, contract, recruitment, data clean, CSR, payment, close…..
- Conduct study feasibility; input in concept/protocol; propose on study timeline and budget. Involve in study strategy making. Present project in 1st tier assessment/Integrated Study Review.
- Develop study related necessary documents
- Submit study periodic progress report.
- Conduct quality management and issue handling.
- Safety report management.
- Manage study budget and cost that meet company requirements, cooperating with MA.
- FMV assessment, contract and payment tracking
- Cooperate well with other stakeholders, including TA, PV, medical compliance, HEOR, RA, GPM, GPT…
- Keep close communication with leading PI and site; Keep positive relationship with principle investigators and investigators.
- Be responsible for study drug provision, study insurance for interventional study.
- For PAC study, delivery the study with high quality and within the timeline to meet regulatory purpose and good result in inspection.
- Window person for assigned Therapeutic area
- Communicate study status with TA regularly; facilitate in new proposal.
- Participate IMT meeting.
- Play important role in TA PMS rolling forecast
- Manage CRO for outsourced study
- Select appropriate CRO according to the company process and project needs, cooperating with the Procurement.
- Work with CRO or business partner to ensure all studies in China on track
- Supervise CRO’s performance in the project, responsible to train and communicate Bayer’s SOP, requirement and police to CRO.
- Take tasks as line manager assigned.
- Bachelor degree or above, major in clinical
- More than 10 year experience in clinical trial area, include more than 2 year in people management and 3 year in project management.
- Experience of leading post marketing study. Knowledge of regulatory requirement.
- Good quality control and risk management ability, good analysis ability.
- Effective communication/negotiation skill, ability to influence others without authority. Good presentation skill.
- Strong leadership
- Good team work spirit
- Good written and oral English for communication
- Good computer skill
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.