BioSpace, Inc.
Associate Director of Clinical Data Management
BioSpace, Inc., Salt Lake City, Utah, United States, 84193
Associate Director of Clinical Data Management
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Associate Director of Clinical Data Management
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BioSpace Associate Director of Clinical Data Management
2 days ago Be among the first 25 applicants Join to apply for the
Associate Director of Clinical Data Management
role at
BioSpace Get AI-powered advice on this job and more exclusive features. Your work will change lives. Including your own.
The Impact Youll Make
Recursion is seeking an Associate Director, Clinical Data Management who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. Youll also play a critical role in the management of all the 3rd party data sources and serve as SME for Data Management. Youll be responsible for leading and delivering initiatives for CDM within the Biometrics group. Youll also be proactive and be keen to collaborate with cross functional groups within the Clinical Development organization and larger Data Science teams at Recursion. Daily, you will be responsible for all the CDM study activities and deliverables, document reviews, oversight of CROs, 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
Lead End to End Data Management activities with hands on ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.Proficiency in project management leading 3-4 outsourced programs, simultaneously. Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables. Works with CRO and Recursion functional groups to complete EDC 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 Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight. Aim to harmonize processes where relevant with other Recursion clinical programs. Serve as a SME for various operational activities and DM processes like EDC, External data standardization, Collection, and Processing. Lead the efforts with Biometrics and Clin Dev organizations for creation and standardization of CRFs Data Review Plans etc. Routinely provide study metrics, planning of deliverables, and propose solutions for data handling/related issues. Lead/Oversee the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCGs, 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. Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements. Strategic and critical thinker who can independently lead initiatives and effectively collaborate cross functionally. Accountable for coordination with other functional groups for submission related activities. Manage strategic input into the design of data flow across EDC and non-EDC data sources across vendor networks. Ensure filing, archival and inspection readiness of all Data Management Trial Master File (TMF) activities. Review and manage external Data Management Budgets, ensure accuracy, and understand trends to support Budget planning and forecasting. Support the development of Clinical Data Management Standard Operating Procedures and Work Instructions. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents.
The Team Youll Join
Reporting to Senior Director, Clinical Data Management and working closely with Biometrics, Clinical Operations and Clinical development Organization, you will be an essential member of the Recursion Development Team. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursions innovative science to patients through clinical development activities.
The Experience Youll Need
Bachelors degree in science, math or computer science 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. 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 / New York City / London / Oxford
.
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 Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is:
$189,000 - $244,000 USD for candidates based in the United States $131,000- $176,400 CAD for candidates based in Canada 64,500- 87,200 GBP for canddiates based in the United Kingdom
You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
The Values We Hope You Share
We act boldly with integrity. 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. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection. We move with urgency because patients are waiting. Speed isnt about rushing but about moving the needle every day. We take ownership and accountability. Through ownership and accountability, we enable trust and autonomyleaders take accountability for decisive action, and teams own outcomes together. We are One Recursion. 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 Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the worlds largest proprietary biological and chemical datasets. Recursion 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, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montral, New York, London, Oxford area, and the San Francisco Bay area. Learn more at www.Recursion.com, or connect onX (formerly Twitter)andLinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, 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 all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursions internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
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Join to apply for the
Associate Director of Clinical Data Management
role at
BioSpace Associate Director of Clinical Data Management
2 days ago Be among the first 25 applicants Join to apply for the
Associate Director of Clinical Data Management
role at
BioSpace Get AI-powered advice on this job and more exclusive features. Your work will change lives. Including your own.
The Impact Youll Make
Recursion is seeking an Associate Director, Clinical Data Management who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. Youll also play a critical role in the management of all the 3rd party data sources and serve as SME for Data Management. Youll be responsible for leading and delivering initiatives for CDM within the Biometrics group. Youll also be proactive and be keen to collaborate with cross functional groups within the Clinical Development organization and larger Data Science teams at Recursion. Daily, you will be responsible for all the CDM study activities and deliverables, document reviews, oversight of CROs, 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
Lead End to End Data Management activities with hands on ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.Proficiency in project management leading 3-4 outsourced programs, simultaneously. Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables. Works with CRO and Recursion functional groups to complete EDC 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 Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight. Aim to harmonize processes where relevant with other Recursion clinical programs. Serve as a SME for various operational activities and DM processes like EDC, External data standardization, Collection, and Processing. Lead the efforts with Biometrics and Clin Dev organizations for creation and standardization of CRFs Data Review Plans etc. Routinely provide study metrics, planning of deliverables, and propose solutions for data handling/related issues. Lead/Oversee the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCGs, 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. Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements. Strategic and critical thinker who can independently lead initiatives and effectively collaborate cross functionally. Accountable for coordination with other functional groups for submission related activities. Manage strategic input into the design of data flow across EDC and non-EDC data sources across vendor networks. Ensure filing, archival and inspection readiness of all Data Management Trial Master File (TMF) activities. Review and manage external Data Management Budgets, ensure accuracy, and understand trends to support Budget planning and forecasting. Support the development of Clinical Data Management Standard Operating Procedures and Work Instructions. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents.
The Team Youll Join
Reporting to Senior Director, Clinical Data Management and working closely with Biometrics, Clinical Operations and Clinical development Organization, you will be an essential member of the Recursion Development Team. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursions innovative science to patients through clinical development activities.
The Experience Youll Need
Bachelors degree in science, math or computer science 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. 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 / New York City / London / Oxford
.
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 Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is:
$189,000 - $244,000 USD for candidates based in the United States $131,000- $176,400 CAD for candidates based in Canada 64,500- 87,200 GBP for canddiates based in the United Kingdom
You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
The Values We Hope You Share
We act boldly with integrity. 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. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection. We move with urgency because patients are waiting. Speed isnt about rushing but about moving the needle every day. We take ownership and accountability. Through ownership and accountability, we enable trust and autonomyleaders take accountability for decisive action, and teams own outcomes together. We are One Recursion. 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 Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the worlds largest proprietary biological and chemical datasets. Recursion 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, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montral, New York, London, Oxford area, and the San Francisco Bay area. Learn more at www.Recursion.com, or connect onX (formerly Twitter)andLinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, 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 all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursions internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Seniority level
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