Role Description Precision for Medicine is looking for Senior / CRAs in Shanghai and Beijing. The Senior / CRA has wide-ranging and broad experience and typically handles the most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include: - Start-up and study implementation activities - On-site monitoring of clinical research studies - Ongoing site management Essential functions of the job include but are not limited to: - Independently oversees all aspects of study site management to ensure patient safety is protected and quality of data generated by managed sites results in consistently low query levels and acceptable Quality Assurance reports. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports. - Manages site start-up procedures including feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. - If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. - Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. - Performs Monitoring Oversight Visits to assess other CRA team members. - Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. - Supports subject/patient recruitment, retention and awareness strategies. - Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. - Reconciles contents of the ISF with the Trial Master File (TMF). - Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. - Develops and maintains good working relationships with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image. - Performs investigational product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. - Verifies issues or risks associated with blinded or randomized information related to IP. - Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. - Identifies and processes Serious Adverse Events according to the procedures defined by the study team. - Demonstrates a full understanding of the SAE reporting process. - Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. - Owns the timely and appropriate resolution of the risk with oversight from project team. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. - Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - May prepare or assist in preparation of study-specific presentations/training materials and tools. - Assists the team managers in the preparation and review of protocols and other study documentation. - Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.). - Assists with review of clinical study reports. - Functions as a mentor, assisting with the training and developing of new employees and junior monitors. - Interacts with clients, participates in proposal activities, including development and client presentations. - Initiates payment requests for investigators. - Travels as necessary according to project needs. - Performs other duties as assigned by management. Qualifications - Minimum Required: 2+ years for a CRA II or 3.5 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. - Significant site management experience or equivalent experience in clinical research. - Global Oncology trials experience preferred. - Other Required: Excellent communication and organizational skills are essential. A team player. - Evidence of a client focused approach. - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. - Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed. - Good in English communication. - Select opportunities require Oncology experience preferably in early phases. Requirements - Graduate, postgraduate degree. - Experience monitoring in rare and complex therapeutic areas. - Experience monitoring EDC trials and EHR records. - Experience in bioharma or relevant therapeutic area. - Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country. - Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines. - Ability to resolve project related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution. Competencies - Exhibits self-motivation and is able to work and plan independently as well as in a team environment. - Understands clinical trials methodology, including a working knowledge of protocols and indications being studied. - Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills. - Collects data of consistently high standard. - Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency. - Demonstrated ability to motivate other members of the project team to meet timelines and project goals. - Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective. - Demonstrated ability to identify training needs for junior CRAs and develop project specific training plans to address those needs. - Demonstrated basic understanding of financial management. - Fluency in English and for non-English speaking countries the local language of country where position based.

We anticipate the application window for this opening will close on - 19 Apr 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentorship, and guidance you need to own your future success. Join us for a career that changes lives. The Vascular Clinical Specialist role will provide detailed technical support for vascular products and procedures to a wide range of clinical base including physicians, nurses and technicians. This individual will support sales representatives with coverage for critical cases, primarily focused on cases with physicians that require technical support on the safe and effective use of our products. RESPONSIBILITIES: - Provide clinical and technical support as well as education to Medtronic customers in vascular disease therapies. Product categories include but not limited to peripheral arterial disease, venous disease, embolization, carotid and fistula maintenance. - Educate and provide information regarding clinical results and the clinical efficacy of our full vascular bag portfolio. - Conducts regular calls to hospitals or clinics to support vascular sales, service and education objectives with high energy, product knowledge confidence to drive improved patient outcomes. - Promotes and establishes education of the company’s products and/or services with one-on-one training sessions, in-service education programs and support of conferences. - Receive direction from the Clinical Service Manager, District Sales Manager with collaboration from sales reps on case and technical support with physicians and staff. - Support district sales strategy: work with sales representatives and managers to achieve business plans. This may include inventory support, and technical case support. - Demonstrate flexibility in scheduling to be able to provide technical case support based on the needs of the customer, including short term notice - Support all business activities including but not limited to training, PO collection and inventory management. - Conduct cycle counts of inventory at customer accounts. Assist with resolving discrepant inventory levels. - Lead efforts in accounts to obtain signed Consignment Agreements (CA) and Inventory Schedules (IS). - Optimize return on invested inventory across the district. Reposition under-performing inventory to accounts with revenue growth opportunity. - Recommend and monitor inventory levels in alignment with customer segmentation and pricing & contract strategies. Coordinate and execute Phase-In and Phase-Out activities for product launches. - Support Area and District sales strategy; work with sales representatives and service leaders to achieve business plan. - Responsible for developing, building, and strengthening long-term relationships with stakeholders including key decision makers, customers and their staff, and administrators that drive business and therapy adoption. - Responsible for pursuing leads, assessing needs, and providing product services to maximize the benefits derived from Medtronic’s vascular products and/or services to understand and confirm customer needs, effectively engages, and overcomes customer objections. - Assess customer needs and feedback regarding new products and/or modifications to existing products and communicates to sales representative. - Partner with sales team and vascular field technician on inventory management initiatives. MUST HAVE - BASIC QUALIFICATIONS: IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME - H.S. Degree and 14+ years OR - Associate degree and 12+ years OR - Bachelor’s degree with 10+ years of experience in healthcare, field sales support, personnel and performance management, project management, or work experience utilizing complex mathematics, mechanical concepts, science or computing   PREFERRED QUALIFICATIONS (optional): - Thorough working knowledge of medical terminology, medical procedures and the medical device industry - Excellent customer service skills - Excellent interpersonal, written and verbal communication skills - Effectively build and maintain positive relationships with peers and colleagues across organizational levels - Strong project management skills and experience coordinating programs - Ability to coordinate/participate in numerous tasks/projects in a fast-paced environment in an organized manner while meeting deadlines - Strong work ethic in accomplishing objectives of the position - Expertise with Microsoft Outlook, Excel, Word and PowerPoint PHYSICAL JOB REQUIREMENTS: - The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions - While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. - Ability to travel domestically over 50% by automobile, plane or other forms of transportation - Lifting/carrying 20 pounds - Sit/stand walk 6-8 hours day - Operate moving vehicle - Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be considered as part of your application Environmental Exposures - Must be able to wear all required personal protective equipment (PPE) - Ability to work in Cath Labs and achieve vendor credentialing - Must have a valid driver’s license in state of residency and active vehicle insurance policy A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):95000-105000 The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Central Review Manager – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed, aids the development of site activation, and develops collaborative relationships with investigators and site personnel. Supports training of new staff and participates in departmental initiatives to aid in process improvements/enhancements. What You’ll Do: - According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. - Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. - Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads. - Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system. - Provides system support (i.e. Activate & eTMF) ). - Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. - Supports scheduling of client and/or internal meetings. - Reviews and tracks local regulatory documents. - Transmits documents to client and centralized IRB/IEC. - Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. - Maintains vendor trackers. - Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. - Assists with study-specific translation materials and translation QC upon request. Education, Experience and Requirements: - Bachelor's degree or higher in Lifesciences. - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). Knowledge, Skills, Abilities: - Ability to work in a team or independently as required - Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively - Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency - Strong customer focus - Flexibility to reprioritize workload to meet changing project timelines - Proven ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout - Good English language and grammar skills and proficient local language skills as needed - Advanced digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems - Ability to successfully complete PPD clinical training program - Self-motivated, positive attitude and good interpersonal skills

• Lead complex projects, programs and submissions • Manage client meetings and collaborate with regulatory, PMs and sponsors • Develop SAPs and iSAPs text and shells with no supervision • Produce and present external company presentations • Review or develop ADAM specifications and collaborate with programmers and junior statisticians • Provide statistical consulting support to sponsors regarding study design and sample size calculations • Demonstrate an understanding of project management-related tasks • Perform sample size calculations • Create randomization and kit schedules independently • Provide support to Data Safety Monitoring Boards (DSMB) • Write blogs and/or white papers for posting on the company website