Senior Manager, Data Management (remote)

Your New Company!
At 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 Manager, Data Management, will report directly to the Director, Data Management and is responsible for providing strategic and operational leadership to the Data Management (DM) service lines within Altasciences. This role oversees the end-to-end data management lifecycle across multiple studies and sponsors, ensuring delivery of high-quality, accurate, and regulatory-compliant clinical dataset for the final analysis. The Senior Manager will lead a team of data managers, effectively collaborate with cross-functional groups (Biostatistics, Clinical Monitoring, Project Management, etc.), and contribute to process optimization and innovation with the DM Department.

What You’ll Do Here

Leadership & Oversight

• Provide leadership and direction to DM project leads, data managers, and support staff across multiple clinical trials and therapeutic areas.

• Serve as the primary DM point of contact for key sponsor accounts, ensuring client satisfaction and project success.

• Oversee resource allocation, project timelines, and budgets within the DM function.

• Mentor, coach, and develop DM staff, fostering a culture of quality, accountability, and continuous improvement.

Clinical Data Management Operations

• Lead the planning, execution, and delivery of all DM activities for assigned studies — from database design through database lock.

• The candidate is required to have proficient working knowledge to review and approve DM documents that govern DM activities, including but are not limited to, the following:

• Data Management Plan
• Annotated Case Report Forms
• Data Validation Plan (Edit Checks)
• CRF Completion Guidelines
• DB Lock Checklist
• Data Transfer Specification / Agreement
• TMF Index
• SAE Reconciliation Process

• Ensure adherence to company SOPs, GCP, ICH, and regulatory requirements (e.g., FDA, EMA).

• Oversee the development, validation, and maintenance of EDC systems and associated tools.

• Collaborate with Biostatistics, Programming, and Clinical Operations to ensure data readiness for interim analyses and final submissions.

Process & Quality Management

• Develop, implement, and enhance DM processes, standards, and tools to drive consistency and efficiency across studies.

• Ensure data quality metrics and KPIs are defined, monitored, and achieved.

• Lead data quality reviews and audits and ensure audit-readiness for sponsor and regulatory inspections.

• Identify and drive opportunities for process automation, EDC optimization, and risk-based data management approaches.

Client & Cross-Functional Collaboration

• Build and maintain strong relationships with sponsor data management and clinical teams.

• Participate in bid defense meetings, proposals, and business development presentations as a subject matter expert.

• Partner with internal stakeholders (Clinical Operations, Biostatistics, Programming, QA) to align timelines, deliverables, and resource needs.

Soft Skills

• Excellent leadership, organizational, and communication skills.

• Strong analytical and problem-solving abilities to address complex issues as they arise.

• Demonstrated ability to manage multiple priorities and sponsor relationships simultaneously but most importantly knowing when to delegate and when not to delegate tasks.

• Strategic mindset with attention to operational detail and data integrity.

What You’ll Need to Succeed

• Bachelor’s degree in health-related sciences or relevant field. Experience may be considered in lieu of education.

• Minimum of 8-10 years of hands on management experience within data management.

• Proficiency with EDC systems (e.g., ClinSpark, Medidata Rave, Oracle InForm, Veeva CDMS, or similar). Please note, Altasciences’ primary EDC system is ClinSpark and candidates that have working ClinSpark experience will be given priority consideration.

• Strong understanding of CDISC/CDASH/SDTM standards and clinical data workflows.

• Familiarity with data coding (MedDRA, WHO Drug), query management, and database lock processes.

• Working knowledge of GCP, ICH E6(R2), FDA 21 CFR Part 11, and related regulatory guidance.

• Experience with project management tools and data visualization platforms (e.g., Spotfire, Power BI) preferred.

• Solid working knowledge of electronic trial master file (eTMF)

• Proficient use of MS Word, MS Project, MS Teams, SharePoint, Excel, Outlook, and Power Point are required. Ability to understand and adapt to multiple information technology (IT) systems is expected.

• Ability to read and interpret technical documents (e.g., SOP, Training Materials, Job Aid, etc.) and industry specific manuals. Ability to author advanced reports and correspondence.

  Ability to speak effectively before groups of customers or employees of the organization.

Other Requirements:

• Excellent verbal and written communication skills.

• Professional attitude and strong leadership skills by recognizing our team members are our greatest assets.

• Ability to collaborate well with a multi-disciplinary team of professionals.

• Client-focused approach to work.

• Solution-focus and ability to creatively solve problems and resolve issues.

• Ability to take initiative and use sound judgment to make independent decisions; however, also recognizes the value in working as a team unit.

• Flexible attitude and an ability to effectively prioritize.

• Proven history of continuous improvement.

• Have a dedicated workspace that is amiable to attend MS Teams meetings with cameras on for face-to-face virtual interaction.

• Travel may be required, which is typically 2-3 times per year, if needed.

What We Offer

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

Altasciences’ Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program 

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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. Join us at Altasciences!