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Moving Science Closer to Health
Senior / Clinical Research Associate
Location
China
Posted
94 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Senior / Clinical Research Associate
Precision Medicine Group
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.
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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. 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Post-Market Clinical Affairs Specialist
SolventumEnabling better, smarter, safer healthcare to improve lives.
Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: Post-Market Clinical Affairs Specialist(Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You’ll Make in this Role As a Post-Market Clinical Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: - Ensuring regulatory compliance across the product lifecycle by leading the planning, execution, and documentation of Post‑Market Clinical Follow‑Up (PMCF) activities in alignment with EU MDR and global regulatory requirements. - Understands the FDA and international requirements and guidance on “Real World Evidence” and uses those concepts to generate data as applicable for US and global markets. - Providing expertise to cross-functional partners to interpret Post‑Market Clinical activities, supporting the safe and effective use of dental products through sound evaluation. - Supporting clinical evaluation and post‑market surveillance processes through systematic literature surveillance, post‑market data review, and integration of PMCF/Real World outputs into clinical evaluations, risk management files, and regulatory submissions. - Developing and maintaining PMCF-related clinical documentation for new product introductions (NPI) and legacy products. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: - Bachelor’s degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND three (3) years of experience in the medical device industry. - Minimum of three (3) years of experience supporting Post‑Market Clinical Follow‑Up (PMCF), post‑market surveillance, and/or clinical evaluation activities in a regulated medical device industry, including development of PMCF plans, reports, and related clinical documentation in alignment with EU MDR and global requirements. Additional qualifications that could help you succeed even further in this role include: - Experience working in the dental device industry - Ability to work effectively in cross-functional and cross-cultural teams. - Strong understanding of global regulatory requirements for medical devices. - Strong knowledge of risk management frameworks. - Excellent communication skills, both written and verbal. - Proven strength in clinical and medical writing. - Ability to manage multiple complex projects simultaneously. - Strategic thinking, critical thinking, reasoning, and interpretive skills - Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills. Work location: Remote – United States Travel: May include up to 10% domestic Relocation Assistance: Not authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:The expected compensation range for this position is $106,000 - $145,750, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County. Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here. Before submitting your application you will be asked to confirm your agreement with the terms.




