(Sr.) Clinical Research Manager

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Job Summary:

1. This position provides strategic guidance, oversight, and effective delivery for clinical programs in area of focus in partnership with cross-functional key stakeholders involved in clinical development.

2. The person may actively participate on cross-functional project teams responsible for the clinical research activities to support Roche Diagnostic China registration of products developed by Roche Group globally, such as, clinical software, instrument platforms, assays, reagents, devices, instruments, systems and biomarkers. Foster cross functional relationships to create a cooperative work environment in support of corporate goals. Ensures alignment across studies and lifecycle teams with current regulatory expectations including ensures compliance with the company SOPs, Policies, Directives, Divisional standards, Declaration of Helsinki, Industry standards, relevant GxPs, both NMPA and/or

international requirements and/or best practices.

3. Be familiar with regulatory requirements and understand regulatory trends and the impact on the project.

4. Identify opportunities to simplify and speed up the institution, EC and HGRAC application process

5. Be familiar with company and department policies/department regulations and SOPs and understand the business relationships, and have the capacity to innovate

6. Be familiar with the product characteristics, guidance and consensus of relevant experts in the field of the research project, and provide key suggestions for the protocol design

7. Identify new risks in a changing environment and effectively identify and control risks

8. Adjust clinical plan according to changes and trends

9. Adapt to volatile environments while insist to focus on long-term strategies

10. Identify opportunities of cost reduction from a functional team perspective to maximize cost effectiveness

11. Provide support, motivate and inspire others to perform at their best

Main Tasks & Responsibilities:

• Plans and executes local studies includes clinical evaluation, clinical trials and/or research studies primarily for non-approved product registration in China, ensures all clinical studies compliance with the company SOPs, Policies, Directives, Divisional standards, Declaration of Helsinki, Industry standards, relevant GxPs, both NMPA and/or international requirements and/or best practices.
• Responsible for the implementation and support maintenance of the clinical trial-related policies, as well as processes and procedures related to the Design Control requirements.
• Deliver clearly goals, deadlines and expectations to ensure the project is achieved.
• Provides input to budgets. Identifies opportunities to reduce costs. May manage portions of larger area(s) budget.
• Support to manages the trial budgets and timelines and accountable for ensuring that budgets and schedules are met.
• Manages internal and external resources to make studies succeed.
• Build up a team and identify the advantages of team members, promote the cooperation of team members advantages. Ensure that the goals and activities of your work or project team are aligned with regional and company goals. And discover the needs of team members in solving problems, and guide them to better understand and solve problems correctly.
• Build up effective communication methods to manage project members/teams and support and motivate others to perform at their best.
• Ensures direct reports has the proper materials, systems access and training to complete job responsibilities and are in compliance with regulations, SOPs and protocols.
• Develop and maintain test materials and equipment management plan, and conduct maintenance and management.
• Provides technical expertise to staff for feasibility assessment ，review and approve the clinical trial documents， IT systems and records (protocols, ICF, data collection forms/plans/reports, monitoring plans, manual of operations, investigator training materials, clinical trials report, study forms, templates and monitoring reports, etc.) and trial conduct (oversee central archiving, study supply management, regulatory submissions and CAPA effectiveness, vendor selection). Provides clinical operation SOP review and expertise.
• Maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners in meeting business goals and ensure operational excellence.
• Acts as liaison and/or subject matter expert with multiple groups within company divisions and other partners to identify, scheduling and implement collaborative studies, regulatory activities, and other programs.
• Manages relationships with key opinion leaders, laboratory chiefs, investigators and key customers.
• Regularly interacts with executive management on work of area(s) that impacts larger organizational goals. 。
• Responsible for establishing plans for area with input from more senior management.
• If apply, be a contact window, develop and maintain a good working relationship with BAs and other dept. to support the cross-functional projects.

Basic Requirements of the Job:

Education& Qualifications:

1. At least Bachelor degree in medical science, preferably in clinical medicine, medical laboratory, biochemistry, pharmacology, bio-engineering and biology

2. Proficiency in English language skills

3. Good command of MS office software application

4. Understand pharmaceutical and/or medical device regulation and ICH/GCP

Experience:

1. At least 10 years of working experience in clinical research, clinical project management, data management in clinical medicine, CRO, pharmaceutical, Medical Device, or in-vitro Diagnostics industries.

2. Two-three years of people management experience is a plus but not prerequisite.

3. Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation.

4. Have the capacity to resolve complex problems through in-depth evaluation of various factors

5. Resolve conflicts constructively from the perspective of all stakeholders

6. Have the capacity to identify and gain support from others to achieve recognition and solutions

7. Have the capacity to communicate and coordinate with multi-functional team

Travel Requirements: Approximately 20% of time local and/or international travel.

Health Conditions:

According to the "Quality Management Regulations for Medical Device Management" and the "Regulations on Quality Management of Pharmaceutical Products", health checks should be conducted at least once a year; if you have infectious diseases or other diseases that may contaminate medical devices or drugs shall not be engaged in related work.

Values & Core Competencies:

1. Demonstrate Roche values of Integrity, Courage, Passion

2. Follow Roche Operating Principles

3. Equip with the core skillsets as required by this role

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.