Rapport Therapeutics
Senior Manager, Clinical Data Management
Rapport Therapeutics, Boston, Massachusetts, us, 02298
When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we're doing this with extraordinary science and awesome people (affectionately called Rapptors).
Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder.
The strength of Rapport comes from our Rapptors - who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you're as excited about this opportunity as we are!
Reporting to the Head of Data Management, as Senior Manager, Clinical Data Management, you will help lead clinical trials and develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
Your impact:
The Senior Manager, Clinical Data Management will help lead clinical trials and provide oversight for outsourced clinical data management activities by working effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools.
Your day-to-day:
Act as Data Management lead on assigned projects Provide CRO oversight and management as needed Review and approve the database design, edit checks, CRF completion guideline, and Data Management Plans drafted by CROs to ensure they are compatible with ensuring CDASH, SDTM and industry standards Work with DB programmers to design (e)CRFs and edit checks in the EDC system Develop test scripts and test data for User Acceptance Testing (UAT) Perform and document database and report UAT Receive, integrate, and reconcile electronic data Perform data review via listings and EDC system, issue and resolve queries Manage queries to ensure data completeness and integrity Review and work with Clinical team on medical coding listings Assist with data listing design for Sponsor data review Perform SAE reconciliation Perform pre-lock and data lock tasks Prepare training materials and user guides for EDC data collection tools Participate in client and team meetings as required Design, generate, and review status metric reports as needed Perform archiving of study databases and related documents Provide input to timelines to ensure timely completion of assigned tasks Provide regular status updates, keeping the team informed of any changes Organize and file study documentation Work with the team to implement technical solutions and resolve issues Additional duties and responsibilities as assigned Must-Haves: Bachelor's Degree in a scientific or health related field or equivalent and 8+ years of clinical data management experience in biotech or pharma, with experience across EDC platforms, Medidata EDC preferred Experience in a clinical research environment, preferably in biotechnology and focused on Neurology and CNS indications; epilepsy, pain and mood disorders a plus Solid technical skills across data platforms; programming experience preferred leading a trial from a Data Management perspective Previous experience designing clinical trials utilizing CDASH and SDTM standard terminology Proficient in cross collaboration with other related functions such as Biostatistics, Statistical Programming, Clinical Operations and Pharmacovigilance Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data Proficient with data visualization software/tools Experience in regulatory GCP inspections/audits preferred Ability to manage multiple projects in a fast-paced environment Excellent communication and time management skills What makes Rapport special:
Every role has meaning. We're determined to discover a better way for patients, and you'll feel the passion from the start. We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities. Your perspective matters. Stick your neck out, share your ideas - we work as a team. We have FUN. We hire smart, dedicated, down-to-earth people that you'll enjoy spending time with. Leadership that CARES - about you, your growth + development. We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston - we make the most of our time together. Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more! You get to be YOU! Show up as you are and make every day count. Your Compensation
We get it. Compensation is an important part of your offer. You shouldn't be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for this role to be $165,000 to $185,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don't stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.
Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Note to Employment Agencies:
Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
CCPA disclosure notice can be found here. #J-18808-Ljbffr
Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder.
The strength of Rapport comes from our Rapptors - who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you're as excited about this opportunity as we are!
Reporting to the Head of Data Management, as Senior Manager, Clinical Data Management, you will help lead clinical trials and develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
Your impact:
The Senior Manager, Clinical Data Management will help lead clinical trials and provide oversight for outsourced clinical data management activities by working effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools.
Your day-to-day:
Act as Data Management lead on assigned projects Provide CRO oversight and management as needed Review and approve the database design, edit checks, CRF completion guideline, and Data Management Plans drafted by CROs to ensure they are compatible with ensuring CDASH, SDTM and industry standards Work with DB programmers to design (e)CRFs and edit checks in the EDC system Develop test scripts and test data for User Acceptance Testing (UAT) Perform and document database and report UAT Receive, integrate, and reconcile electronic data Perform data review via listings and EDC system, issue and resolve queries Manage queries to ensure data completeness and integrity Review and work with Clinical team on medical coding listings Assist with data listing design for Sponsor data review Perform SAE reconciliation Perform pre-lock and data lock tasks Prepare training materials and user guides for EDC data collection tools Participate in client and team meetings as required Design, generate, and review status metric reports as needed Perform archiving of study databases and related documents Provide input to timelines to ensure timely completion of assigned tasks Provide regular status updates, keeping the team informed of any changes Organize and file study documentation Work with the team to implement technical solutions and resolve issues Additional duties and responsibilities as assigned Must-Haves: Bachelor's Degree in a scientific or health related field or equivalent and 8+ years of clinical data management experience in biotech or pharma, with experience across EDC platforms, Medidata EDC preferred Experience in a clinical research environment, preferably in biotechnology and focused on Neurology and CNS indications; epilepsy, pain and mood disorders a plus Solid technical skills across data platforms; programming experience preferred leading a trial from a Data Management perspective Previous experience designing clinical trials utilizing CDASH and SDTM standard terminology Proficient in cross collaboration with other related functions such as Biostatistics, Statistical Programming, Clinical Operations and Pharmacovigilance Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data Proficient with data visualization software/tools Experience in regulatory GCP inspections/audits preferred Ability to manage multiple projects in a fast-paced environment Excellent communication and time management skills What makes Rapport special:
Every role has meaning. We're determined to discover a better way for patients, and you'll feel the passion from the start. We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities. Your perspective matters. Stick your neck out, share your ideas - we work as a team. We have FUN. We hire smart, dedicated, down-to-earth people that you'll enjoy spending time with. Leadership that CARES - about you, your growth + development. We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston - we make the most of our time together. Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more! You get to be YOU! Show up as you are and make every day count. Your Compensation
We get it. Compensation is an important part of your offer. You shouldn't be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for this role to be $165,000 to $185,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don't stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.
Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Note to Employment Agencies:
Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
CCPA disclosure notice can be found here. #J-18808-Ljbffr