Associate Director, Clinical Data Management
- Employer
- Recursion
- Location
- Remote Opportunity
- Start date
- Sep 7, 2024
View more categoriesView less categories
- Discipline
- Clinical, Clinical Data, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Details
The Impact You’ll Make
Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking an Associate Director, Clinical Data Mangement who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. You’ll also play a critical role in the management of all the 3rd party data sources and serve as SME for Data Management. You’ll be responsible for leading and delivering initiatives for CDM within the Biometrics group. You’ll 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 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:
- Lead End to End Data Management activities for outsourced studies and manage DM and external vendor oversight activities and deliverables.
- Represent Data Management function at Clinical Study Meetings and ensure alignment of expectations between the CRO and Recursion for all the data related deliverables.
- Work with CRO and Recursion functional groups to complete EDC set up and other systems such as IRT, ePRO etc.,
- Establish Vendor Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight.
- 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 CRF’s Data Review Plans etc.,
- Lead/Oversee 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.
- Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
- 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.
Location:
Making Salt Lake City your home base is ideal, however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.
The Team You’ll 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 Recursion’s innovative science to patients through clinical development activities.
The Experience You’ll Need
- Bachelor’s 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.
How You’ll be Supported
- You will be offered ample support from the Head of Clinical Data Management with respect to onboarding within Recursion and more specifically within CDM, Biometrics and ClinDev organizations.
- Opportunity to collaborate with cross functional leaders across Recursion and be part of the tech-bio revolution.
- Opportunity to make a meaningful impact on patients’ lives.
- Option to participate in coaching like BetterUp for leadership skills and development programs.
- Option to attend conferences to learn more from colleagues, networks, and more to better your skillset.
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:
- Developing: $ 154,000
- Skilled: $ 171,000
- Expert: $ 188,000
To learn more about our level within levels, clickhere.
You will also be eligible for bonuses and equity compensation + our comprehensive benefits package for United States based candidates. The range displayed on each job posting reflects target ranges for US new hire salaries and is determined by job, level, and market factors.
During the interview selection process, you will connect with a Talent Acquisition Partner who will be your advocate and ally to ensure you receive the appropriate compensation that meets your needs for your skills, experience, and relevant education/training, while also reviewing our very competitive total rewards package.
#LI-CP1
The Values That We Hope You Share:
- We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.
- We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.
- We Deliver: We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover.
- Act Boldly with Integrity: No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.
- We are One Recursion: We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.
Recursion spends time and energy connecting every aspect of work to these values. They aren’t static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work. You can read more about our values and how we live them every day here.
More About Recursion
Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s 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 inSalt Lake City, where it is a founding member ofBioHive, the Utah life sciences industry collective. Recursion also has offices in London, Toronto, Montreal and the San Francisco Bay Area. Learn more atwww.Recursion.com, or connect onX(formerly Twitter) andLinkedIn.
Recursion is an Equal Opportunity Employer that values diversity and inclusion. 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. Recursion welcomes and encourages applications from people with disabilities. 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 Recursion’s 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.
Company
Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering to radically improve the lives of patients and industrialize drug discovery. Our team is working to solve some of the hardest, most meaningful problems facing human health today.
Recursion is proudly headquartered in Salt Lake City, Utah with offices in Toronto, Montreal and Milpitas, California. We're working to solve some of the most meaningful problems facing human health today. Come do the most impactful work of your career at a company that prioritizes belonging, collaboration and career development.
- Website
- https://www.recursion.com/
- Phone
- 801-587-1629
- Location
-
41 S. Rio Grande Street
Salt Lake City
Utah
84101
United States
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