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Senior Lead Data Manager - Topeka, United States - Altasciences
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Description
Your New CompanyAt Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.
No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe.
By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.
We are better together and together We Are Altasciences.About The Role
The Senior Lead Data Manager is responsible for all data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies.
In addition, the Senior Data Manager has an active role in continuous improvement and acts as a leader in the department as demonstrated by successful mentoring and consistent study delivery over time.
What You'll Do Here:
Follow department and company standard operating procedures
(SOPs), forms, templates and policies. Provide feedback and update
these guidelines as needed.
Act as the primary Data Management contact for the client and project
team, proactively managing sponsor and interdepartmental
expectations.
Develop strong client relationships that are driven by consistent study
delivery in terms of quality and timeliness.
Develop, review, and maintain all study Data Management
documentation.
Coordinate with Database Developers to ensure effective database
build and timely go-live to meet the needs of the project.
Ensure the clinical database adheres to Clinical Data Acquisition
Standards Harmonization guidelines allowing for optimal SDTM dataset
programming. Suggest design for standard and non-standard data
collection, identify any gaps in data collection, and challenge collection
of unnecessary data.
Define electronic case report form (eCRF) and edit check specifications
to support data collection and analysis required per protocol.
Take responsibility for and guide effective quality control (QC) review
and user acceptance testing (UAT) of the clinical database prior to its
release into production, including oversight of staff performing these
tasks.
Delegate and collaborate with Data Managers on data management
cleaning activities including listing review, issuing and closing queries,
and external vendor data reconciliation per protocol, department and
client standards, and International Conference on Harmonisation (ICH)
Good Clinical Practice (GCP) guidelines within the timelines expected by
the client and project team
Ensure data are properly reviewed in accordance with the Data
Management Plan (DMP) and department and sponsor guidelines and
that cleaning is effective and timely.
Track eCRFs to ensure appropriate updates and that all missing or
discrepant data are queried appropriately. Monitor key study metrics
and provide status reports to the sponsor and project team.
Maintain the Data Management documentation for the trial master file
(TMF) according to department and Project Management processes.
Provide input on study timelines, identify risks, and communicate
mitigation strategies to the Project Manager.
Provide input into improving the efficiency of data management tasks.
Lead and participate in intradepartmental or interdepartmental process
and quality improvement initiatives.
Oversee direct reports as assigned.
Mentor and train other team members and/or develop training
materials as needed.
Other duties as assigned.
What You'll Need to Succeed
:
Bachelor's Degree in programming, health-related sciences, or relevant field
Experience may beconsidered in lieu of education.
Professional attitude and strong interpersonal skills.
Ability to work well with a multi-disciplinary team of professionals.
Client-focused approach to work.
Flexible attitude with respect to work assignments and new learning.
Ability to prioritize workload.
Understanding of clinical research and the relationship of DataManagement in the clinical study process.
Proven history of continuous improvement.
Strong technical aptitude and ability to adapt to multiple data
management platforms.
Strong knowledge of electronic data capture (EDC) clinical data
management systems.
Good computer skills (Microsoft Word, Excel, and Power Point) and
ability to understand and adapt to various information technology (IT)
systems.
What We Offer
The pay range estimated for this position is $66,000-$96,000
annually. Please note that hourly rates/salaries vary ,within the range based on
factors including, but not limited to, prior relevant experience, skills,
education, certification, location as well as internal equity and market data
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences' Benefits Package Includes:Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs
Telework when applicable
Training & Development Programs
Employee Referral Bonus Program
Annual Performance Reviews
#LI-MB1
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
Altasciences is an equal opportunity employer committed to diversity and inclusion.
Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives.
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.
Reasonable accommodations for persons with disabilities during the recruitment process are available upon request.Altasciences warrants adherence to applicable labor laws, including non-use of forced, prison or child labor, in violation of US and Canada laws, in its operations or supply chain.
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