Biomedical Data Stewardship Manager

Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts.

Payrate: $60.00 - $62.00/hr.
 
Summary:
In this role, we are looking for individuals with a strong understanding of end-to-end standards and data flow. Keeping the “end-in-mind” as we partner within the Biomedical Data Stewardship (BMDS) team to ensure the correct data is being collected with our standard protocol and SAP language and data collection standards for analysis and reporting purposes. The position will primarily work within BMDS but may also collaborate with statistical programmers at Company to promote the usage of standards. This role will have an opportunity to work across Company’s therapeutic areas to create and maintain clinical trial data standards. This role will also involve supporting a standards data repository with entry and validation of Company’s SDTM standards.
 
Responsibilities:

• Build a comprehensive understanding of Company’s data standards structure across stages of development
• Build a comprehensive understanding of the Metadata Repository (MDR) product
• Develop mappings between Company’s data collection and SDTM standards within MDR
• Develop and maintain guidance documents supporting the analysis and reporting standards
• Ensure that Company decisions with respect to SDTM implementation are CDISC-compliant and are in line with industry and regulatory guidance
• Provide input to continuously improve the management of analysis and reporting standards and metadata

 
Basic Qualifications:

• Doctoral degree and 4 years clinical trials experience OR
• Master’s degree and 6 years clinical trials experience OR
• Bachelor’s degree and 8 years clinical trials experience
• Proficient in CDISC SDTM modeling, CDISC IGs and TAUGs and regulatory guidance documents
• Effective communication and collaboration skills

 
Preferred Qualifications:

• 10 or more years of pharmaceutical/biotech experience in data management, biostatistics or programming
• Proven standards development experience
• Experience in designing, analyzing, and reporting clinical trials
• Independent and self-motivated

 
Top 3 Must Have Skill Sets:

• SDTM specifications development
• Standards development
• Independent and self-motivated / Strong organizational skills / Strong communication and collaboration skills

 
Pay Transparency: The typical base pay for this role across the U.S. is: $60.00 - $62.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 

Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.

Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to :messages or by contacting

privacy@aditiconsulting.com

. 

For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy
 
#AditiConsulting                              
#26-05051