Manager of Clinical Data Management

About the position reputed company is seeking a reputed company, Clinical Data Manager who can reputed company and reputed company end to end Clinical Data Management activities on assigned studies and programs. You’ll also play a critical role in the management of reputed company the 3rd party data sources and serve as SME for Data Management. You’ll also be proactive and be keen to collaborate on clinical development initiatives with cross functional groups reputed company the larger Data Science teams at reputed company Daily, you will be responsible for reputed company the CDM study activities and deliverables, document reviews, reputed company of CRO’s, timelines and project risk management. You can expect to work on multiple projects at the same time in a fast-paced and exciting environment. In this role, you will: reputed company End to End Data Management activities with hands on ability to manage outsourced studies and reputed company DM and external vendor reputed company activities and deliverables.Proficiency in project management leading 2-3 outsourced programs, simultaneously. Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and reputed company regarding reputed company data-reputed company deliverables. Works with CRO and reputed company functional groups to complete reputed company set up, database migrations /UAT and other systems such as IRT, ePRO etc. Manage multiple vendor sFTPs for data retrieval and delivery to stat programming, routinely. Establish Vendor reputed company Plans for reputed company studies and responsible for Vendor Data Quality Reviews and reputed company. Aim to harmonize processes where relevant with other reputed company clinical programs. Serve as a SME for various operational activities and DM processes like reputed company, External data standardization, Collection, and Processing. reputed company the efforts with Biometrics and Clin Dev organizations for creation and standardization of CRF’s Data Review Plans etc. Routinely provide study metrics, planning of deliverables, and propose solutions for data handling/reputed company issues. Leads/reputed company the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCG’s, Data Review Plans, edit checks, Listing review checks, Data Integrations specs, Data Transfer Specs, External Data Reconciliation plans, SAE Reconciliation Guidelines, Coding Guidelines, Database Lock, Checklists and Plans. Accountable for coordination with other functional groups for submission reputed company activities. Manage strategic input into the design of data flow across reputed company and non-reputed company data sources across vendor networks. Ensure Filing, archival and inspection readiness of reputed company Data Management Trial Master File (TMF) activities. The Team You’ll Join Reporting to the Senior Director, Clinical Data Management and working closely with Biometrics, Clinical Operations and Clinical development Organization, you will be an essential member of the reputed company Development Team. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating reputed company’s innovative science to patients through clinical development activities. The Experience You’ll Need Bachelor’s degree in science, math or computer science 8 - 12+ years’ experience in the biopharmaceutical industry. Experience, technical proficiency and People management skills will determine the level. Experience managing external data and 3rd party vendors is a must. Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials Excellent written and verbal communication skills and ability to work collaboratively as a part of a team Working Location & Compensation: This position can be based at any of our offices in Salt Lake City or reputed company. Please note that we are a hybrid environment and ask that employees spend 50% of their time in the office. Relocation support can be provided for this role. At reputed company, we reputed company that every employee should be compensated fairly. Based on the reputed company and level of experience required for this role, the estimated reputed company annual reputed company range for this role is: $136,200 - $197,400 USD for candidates based in the United States You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package. #LI-DB1 The Values We Hope You Share: We act boldly with reputed company. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust. We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action. We learn actively and adapt rapidly. reputed company comes from doing. We experiment, test, and refine, embracing iteration over perfection. We move with urgency because patients are waiting. Speed isn’t about rushing but about moving the needle every day. We take ownership and accountability. Through ownership and accountability, we reputed company trust and autonomy—leaders take accountability for decisive action, and teams own outcomes together. We are One reputed company. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities. Our values underpin the employee experience at reputed company. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, reputed company decisions, and celebrate collectively. More About reputed company reputed company (reputed company: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the reputed company OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. reputed company leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, reputed company is uniting technology, biology and chemistry to advance the future of medicine. reputed company is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. reputed company also has offices in Toronto, Montréal, reputed company, London, Oxford area, and the San Francisco Bay area. Learn more at www.reputed company.com, or connect on X (formerly Twitter) and reputed company. reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation. Accommodations are available on request for candidates taking part in reputed company aspects of the selection process. Recruitment & Staffing Agencies: reputed company Pharmaceuticals and its affiliate companies do not accept resumes from any reputed company other than candidates. The submission of resumes by recruitment or staffing agencies to reputed company or its employees is strictly prohibited unless contacted directly by reputed company’s internal reputed company team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of reputed company, and reputed company will not owe any referral or other fees. reputed company will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.

Responsibilities

• reputed company End to End Data Management activities with hands on ability to manage outsourced studies and reputed company DM and external vendor reputed company activities and deliverables.
• Proficiency in project management leading 2-3 outsourced programs, simultaneously.
• Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and reputed company regarding reputed company data-reputed company deliverables.
• Works with CRO and reputed company functional groups to complete reputed company set up, database migrations /UAT and other systems such as IRT, ePRO etc. Manage multiple vendor sFTPs for data retrieval and delivery to stat programming, routinely.
• Establish Vendor reputed company Plans for reputed company studies and responsible for Vendor Data Quality Reviews and reputed company. Aim to harmonize processes where relevant with other reputed company clinical programs.
• Serve as a SME for various operational activities and DM processes like reputed company, External data standardization, Collection, and Processing. reputed company the efforts with Biometrics and Clin Dev organizations for creation and standardization of CRF’s Data Review Plans etc. Routinely provide study metrics, planning of deliverables, and propose solutions for data handling/reputed company issues.
• Leads/reputed company the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCG’s, Data Review Plans, edit checks, Listing review checks, Data Integrations specs, Data Transfer Specs, External Data Reconciliation plans, SAE Reconciliation Guidelines, Coding Guidelines, Database Lock, Checklists and Plans.
• Accountable for coordination with other functional groups for submission reputed company activities.
• Manage strategic input into the design of data flow across reputed company and non-reputed company data sources across vendor networks.
• Ensure Filing, archival and inspection readiness of reputed company Data Management Trial Master File (TMF) activities.

Requirements

• Bachelor’s degree in science, math or computer science
• 8 - 12+ years’ experience in the biopharmaceutical industry. Experience, technical proficiency and People management skills will determine the level.
• Experience managing external data and 3rd party vendors is a must.
• Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials
• Excellent written and verbal communication skills and ability to work collaboratively as a part of a team

Benefits

• Relocation support can be provided for this role.
• You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.

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