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The era of genetic neuroscience has arrived
TMF Specialist
Location
United States
Posted
101 days ago
Salary
0
Job Description
TMF Specialist
Praxis Precision Medicines, Inc.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We’re looking for a TMF Specialist who takes pride in precision and understands that great clinical science depends on disciplined execution. You will own the organization, quality review, and integrity of essential trial documents within our electronic Trial Master File (eTMF) system. Your work ensures our studies stand up to regulatory scrutiny — and ultimately helps us deliver therapies to patients faster. - Review and quality check trial documents to ensure accuracy and compliance. - File and maintain essential records in the eTMF system. - Flag and track quality issues, ensuring they are resolved quickly. - Support filing and archiving across multiple clinical studies. - Work closely with TMF Operations Lead to update filing processes and guidelines. - Help manage periods of high document submission. Qualifications - Bachelor’s degree or equivalent - 2-4 years of experience in clinical trials, TMF, or related roles (Sponsor, CRO, or Site) - Knowledge of ICH-GCP, good documentation practices, and eTMF systems (e.g., Veeva) - Organized and detail oriented - Great communicator and team player Requirements The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Benefits - 99% of the premium paid for medical, dental and vision plans. - Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. - Dollar-for-dollar match up to 6% on eligible 401(k) contributions. - Long-term stock incentives and ESPP. - Discretionary quarterly bonus. - Extremely flexible wellness benefit. - Generous PTO, paid holidays, and company-wide shutdowns. - A collaborative and inspiring work environment. - Annualized base salary compensation in the range of $75,000 — $93,000 USD. Company Description Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis, we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity, and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Job Requirements
- Bachelor’s degree or equivalent
- 2-4 years of experience in clinical trials, TMF, or related roles (Sponsor, CRO, or Site)
- Knowledge of ICH-GCP, good documentation practices, and eTMF systems (e.g., Veeva)
- Organized and detail oriented
- Great communicator and team player
- The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
- Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO, paid holidays, and company-wide shutdowns.
- A collaborative and inspiring work environment.
- Annualized base salary compensation in the range of $75,000 — $93,000 USD.
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Researches solutions to questions or problems (e.g., Catheter, Console, Generator support) - Educational Support - Educates and trains physicians, hospital personnel and office staff on technical matters relating to AFS products and related procedures. - One-on-one training sessions - In-service education programs - Seminars and/or outside symposiums - Assists RM and field training department in educating/training new Clinical Specialists and Account Managers - Provides training and resources for hospital staff to enable them to conduct training for their personnel - Sales Support - Updates sales representatives concerning procedure. Immediately notifies Account Manager regarding issues or problems requiring follow-up - Serves as effective Medtronic CAS representative to physicians and support staff regarding Medtronic CAS products, service and support - Promotes the safe and effective use of Medtronic CAS products and related procedures - Understands national, regional and territory sales objectives. Works in partnership with Account Manager to achieve exceed goals 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. 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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. 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PR) locations (USD):$100,000.00 - $120,000.00 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. 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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. 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(“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.
We anticipate the application window for this opening will close on - 16 Mar 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 We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role.At Medtronic, the Clinical Specialist supports the Pelvic Health groups in the areas of surgical coverage, follow-up, support, troubleshooting, customer service and education within a territory. In certain instances, this role may be engaged in basic market development activities depending upon the needs of the assigned territory. This is a field-based role. We are seeking a committed professional to join our team, required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role, which also includes travel outside the territory, presenting opportunities for broader engagement. 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This is achieved by coordinating: one on one sessions, in service education programs, seminars and/or outside symposiums. - Assists district manager and in-house training department in education/training of new employees in the district (therapy consultants, clinical specialists, field clinical engineers, etc.). - Provides sales support during or following cases such as completing the necessary documentation (for example: implant registration, temporary id cards, packing list) and is able to execute invoices in a variety of different situations. This position is able to place an order with customer service for pending purchase orders and product replacement. - Maintains open and effective communication with all district personnel, customers and other Medtronic employees. - Contributes to the completion of milestones associated with specific projects at the regional and/or national level. - Has an understanding of all quality policy/system items that are applicable. - Follows all work/quality procedures to ensure quality system compliance and high quality work. - Performs other related activities, as assigned. - 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. We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role. We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader —that’s why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. To learn more about Inclusion & Diversity at Medtronic Click Here. Qualifications: Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume. - High School Diploma or GED AND a minimum of 6 years of patient care/clinical experience; or - Associate’s Degree AND a minimum of 4 years of patient care/clinical experience; or - Bachelor’s Degree AND a minimum of 2 years of patient care/clinical experience. Nice to Have: - Bachelor’s or Master’s Degree - Clinical skill and knowledge (ex. ability to conduct a simple trial, implant and/or refill a pump) - Clinical experience with implantable Neuromodulation products and stim experience - Experience in servicing medical personnel on product use - Experience working with a medical device or pharmaceutical company and clinical experience in a specialty area: urology, surgical, RN, neurology, neurosurgery, orthopedic, operating room, or home health care - Ability to communicate effectively with sales and health care professionals - Ability to coach others on use of products and clinical applications - Excellent organizational skills - Ability to prioritize under pressure - Ability to manage multiple tasks simultaneously **Preference will be given to qualified local candidates and candidates with Medtronic experience Additional Job Requirements: 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. The physical demands described within the Day in the Life 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. 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. - 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. Must be able to drive approximately 50% of the time within assigned territory and may require overnight travel. Business Description: Pelvic Health is part of the Neuroscience Portfolio. Our therapies treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies so we can help potentially millions of people get their lives back Click here to learn more about products. 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):$76,000.00 - $95,000.00 - $114,000.00 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.



