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.
MAIN TASKS AND RESPONSIBILITIES
1. Manage 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.
2. Manage investigator/institution initiated study (IIR)
• Work with MA for IIR budget and timeline planning
• FMV assessment, contract and payment tracking
• Track study progress
• Be responsible for study drug provision if appropriate
• Maintain study related necessary documents
• SAE report management
3. 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
4. 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.
5. Take functional tasks when needed, such as local OI development, GNIS community member, IPAT super user, QC and training, take assigned initiatives. Provide mentor for new comer.
6. Upon SO structure, Line manager for CRA or MRPA:
• Assign qualified CRA/MRPA to individual PMS according to their experience and workload, under the insourcing CRA strategy from procurement and study resources needs.
• Supervise CRA or MRPA performance in the projects, and give support to them if need.
• Ensuring post-marketing studies' implementation under the support of CRA or MRPA in accordance with protocol, GCP, SOP/OI and timeline, throughout the whole process of studies, for example but not limited: investigator meeting, trial initiation, contract, recruitment, data clear, payment, close.....
• Identify the problem in trial operation aspect, and improve the quality and process.
• Cooperate with Project Lead closely to improve the quality of trials and process continuously.
• Studies budget well controlled and matches company requirements.
• Manage and develop staff: Evaluate and allocate workload for each team member; Set up objectives for team member and conduct periodic performance review; Identify the strength and weakness of each team member, and set up development plan for internal FTE; Provide relevant coach and training to MRA/MRPA to match PMS and members’ needs; Cultivate a cooperative and high efficient working environment and morale; Cooperate with the insourcing CRO about the recruitment, maintenance and management.
WHO YOU ARE
1. Bachelor degree or above, major in clinical medicine or pharmacology
2. More than 6 year experience in clinical research area including 2 years of project management experience is mandatory and 1 year in people management preferable. Experience of leading post marketing study is preferred
3. Effective communication/negotiation skill
4. Strong leadership
5. Good written and oral English for communication within Bayer
6. Good computer skill
7. Team work spirit
8. Skill to coach and motivate others.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 444221
Functional Area: 临床研发&运营