Summary of The Position:
The Lead Data Manager provides functional leadership and oversight of Data Management activities across clinical projects within Total Trials. This role is responsible for ensuring high-quality, compliant, and efficient data management deliverables across multiple studies or programs.
The Lead Data Manager acts as a senior technical expert and mentor within the Data Management team, supporting the development of staff, driving best practices, and contributing to continuous improvement initiatives. The role works closely with cross-functional teams, sponsors, and vendors to ensure data integrity, regulatory compliance, and successful project delivery.
Essential Functions:
-
Lead and oversee data management activities across multiple clinical trials or complex programs.
-
Provide functional oversight, guidance, and support to Data Manager and Senior Data Managers.
-
Mentor, coach, and support the training and professional development of Data Management staff.
-
Serve as the primary escalation point for data-related issues within assigned projects.
-
Ensure consistency, quality, and compliance of all data management deliverables in line with:
-
Study protocols
-
ICH-GCP guidelines
-
Regulatory requirements (FDA, EMA, and other global authorities)
-
Company procedural documents
-
Provide expert input into:
-
Data Management Plans
-
CRF design and review
-
Database design, validation, and testing
-
Edit check specifications
-
Data cleaning and reconciliation strategies
-
Oversee:
-
Data review, query management, and reconciliation activities
-
Coding processes using standard dictionaries (e.g., MedDRA,WHODrug)
- User Acceptance Testing (UAT)
-
Collaborate cross-functionally with Biostatistics, Clinical Operations, and other stakeholders to ensure alignment of data collection and reporting requirements.
-
Liaise with external vendors and support oversight of outsourced data activities.
-
Contribute to process improvement initiatives, standardization efforts, and implementation of best practices across the Data Management function.
-
Support project planning, timelines, and resource allocation in collaboration with the Data Management Director.
-
Contribute to client interactions, including meetings, deliverables, and issue resolution.
-
Assist with proposal development and provide subject matter expertise for bids, where required.
-
Maintain oversight of study documentation and ensure completeness within Trial Master Files (TMF).
-
Provide guidance and oversight to team members, including workload coordination, technical support, and career development.
-
Any other duties and responsibilities as may be assigned from time to time.(For all Positions -List of role responsibilities, ensuring the first bullets are the primary duties.)
Knowledge, Skills, and Abilities:
-
Strong leadership and mentoring capability within a clinical data environment.
-
Advanced knowledge of clinical data management processes, systems, and documentation.
-
In-depth understanding of global clinical research regulations and guidelines.
-
Ability to oversee multiple projects and prioritize effectively in a dynamic environment.
-
Strong problem-solving, analytical thinking, and decision-making skills.
-
Excellent organizational and planning abilities.
-
Strong interpersonal and stakeholder management skills.
-
Effective written and verbal communication skills in English.
-
Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems.
-
Strong working knowledge of data standards and best practices (e.g., CDISC).
-
High attention to detail and commitment to data quality and integrity.
-
Proven ability to build strong client relationships and possesses good client engagement skills
-
Exceptional interpersonal and communications skills.
-
Ability to lead high performing teams and achieve key objectives.
Position Requirements
Education: Bachelor's Degree or its international equivalent in health, behavioral, or life sciences or related field; or an equivalent combination of education and relevant work experience.
Preferred Job-related Experience: Minimum of 8–10 years of experience in data science or clinical data management within a clinical research environment, including demonstrated experience in leading projects and mentoring team members.
Additional Eligibility Qualifications:
-
Training and proficiency in Good Clinical Data Management Practices (GCDMP).
-
Experience with multiple EDC systems.
-
Experience with coding dictionaries such as MedDRA and WHO Drug.
Preferences:
-
Experience supporting global clinical trials across multiple regions.
-
Experience contributing to process improvement or innovation initiatives.
-
Prior experience in a functional lead or supervisory capacity is advantageous.
Special Position Requirements:
-
Proficiency in systems such as EDC platforms, CTMS, SharePoint, and Microsoft Office Suite.
-
Working knowledge of SQL, SAS, or R is advantageous.
-
Availability for flexible and extended hours in support of business needs across multiple time zones
-
Must have Oracle Clinical Onesystem Experience.
Physical Expectations:
-
Typical office environment.
-
Ability to sit and stand for extended periods of time.
-
Ability to lift or move5-15lbs.or 2.26 – 6.8kg.
Travel Requirements:
Expected travel time is less than 10 % for this position.
This job description is not intended to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
Total Trials Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
