Clinical & Digital Health Evidence Manager

岗位职责和要求

The Clinical & Digital Health Evidence Manager will work within the Clinical & Digital Health Evidence Team in China.

The Clinical & Digital Health Evidence Manager is responsible for the operational management of complex clinical studies for adult nutrition products in China, with a key focus on FSMP registration studies, post-launch studies, IIS collaboration and local evidence generation This includes preparation, initiation, conduct, progress reporting and closure of the studies according to the Clinical Study Plan, China GCP, applicable legislation and Standard Operating Procedures. He or she will be responsible for the operational feasibility of the protocol and translate the clinical study protocol to the clinical study plan. He or she is like the spider in the web of a multi-disciplinary team, leading the clinical project team and responsible for ensuring the quality, timeline and budget of the clinical studies. In addition, he or she will be responsible for the selection and management of external vendors,for example suppliers, sites and CROs.

Responsibilities include:

• Lead the conduct of adult nutrition clinical projects, including FSMP registration studies, post-launch studies and IIS-related projects where applicable, from start to end in accordance with protocol, Good Clinical Practice, SOPs and local regulation/legislation.

• Coordination in the preparation, execution and data management /analysis phase.

• To assess operational feasibility of the protocol

• Responsible for evaluation and selection of (potential) investigators

• Coordinate selection of third parties (CRO’s, warehouses, central labs, etc) involved in research projects.

• Manage the CROs and other vendors at research project study level and monitor quality of the vendors.

• Develop study documents (Protocol, ICF, CRFs, etc.)

• To conduct selection visits and co-visits with the CRO for initiation, monitoring and close-out of sites

• Arrange for regulatory and Ethics submission and approval, with the ability to support FSMP registration-related clinical documentation and cross-functional coordination.

• Ensure registration studies are conducted with strong compliance, audit readiness and timely delivery, and lead preparation, coordination and follow-up for global and authority clinical audits to support successful audit outcomes.

• Support post-launch evidence generation and IIS collaborations, including scientific input, operational feasibility assessment, site/KOL coordination, risk management, study document review and appropriate governance follow-up.

• Manage the project budget and site and third party contracts and payments.

• Coordinate the process of data management and statistical analyses.

• Reviewing and further develop local operation procedures

The Clinical & Digital Health Evidence Manager is ultimately responsible for the quality of work as delivered by the entire multidisciplinary project team (including vendors) with regards to ChinaGCP, Global Clinical Policy timelines and budget.

The Clinical & Digital Health Evidence Manager is expected to show clear leadership, maintain a proactive and flexible mindset, drive project progress, and clearly contribute to further development of the team and the ways of working.

Functional Experience

- Experience in clinical research for Adult nutrition products is preferred, including nutrition, medical nutrition and/or FSMP experience, especially China FSMP registration studies, post-launch studies and IIS-related projects. If FSMP experience is not available, experience in medical device and/or pharmaceutical clinical trials, particularly oncology trials, is preferred.

- Experience with Real World Evidence and utilizing digital platforms in clinical projects (preference)

- Strong Project Management skills, including project planning, risk identification and mitigation, escalation management, budget management, supply management, vendor management and progress control, in a regional or global R&D environment in the nutrition, medical devices and/or pharmaceutical industry.

- In depth Knowledge of conducting clinical studies according to ICH-GCP guidelines and China regulation and legislation

- Excellent communication skills and responsiveness to interact with a multidisciplinary project team, external parties and international stakeholders across local, regional and global teams.

- Knowledge of clinical research methodology and statistics

- Good leadership, interpersonal skills and teamwork, with a flexible, proactive and self-driven working style.

- Strong learning agility and business acumen, with the ability to understand evolving business needs, re-prioritize appropriately and translate business questions into pragmatic clinical evidence plans.

- Able to share knowledge with team members to enrich their development

Leadership

· Learns fast, grasps the essence of nutrition field and science behind nutritional products.

· Raises the bar and is never satisfied with the status quo

· Creates a learning environment, open to suggestions and experimentation for improvement

· Embraces the ideas of others, nurtures innovation and manages innovation to reality

Ability to innovate and solve challenges with unique approaches

Fluent in spoken and written English and delivering presentations

Open minded

Critical thinking and problem solving (can-do mentality)

Planning and organizing

Decision-making

Initiative and self-motivation

Influencing

Team player

· Ability to focus on the long-term vision while remaining adaptable to changing business needs, portfolio priorities and evidence requirements

And skills:

Networking