468 Senior Clinical Data Manager jobs in Kenya

• Develop and maintain comprehensive Clinical Data Management Plans (CDMPs) for assigned studies.
• Design, build, and validate EDC databases according to study protocols and data standards.
• Develop data validation specifications, edit checks, and data query management processes.
• Perform data review and analysis to identify data discrepancies, inconsistencies, and quality issues.
• Generate and track data queries to resolve identified issues with data entry personnel and site staff.
• Oversee data cleaning activities and ensure timely resolution of all data issues.
• Perform data reconciliation with other databases (e.g., safety, clinical supplies).
• Ensure compliance with GCP, ICH guidelines, and relevant regulatory requirements.
• Collaborate effectively with clinical research associates (CRAs), biostatisticians, programmers, and medical reviewers.
• Contribute to the development and implementation of data management SOPs and guidelines.
• Participate in study start-up, maintenance, and close-out activities.
• Generate data management reports for internal and external stakeholders.
• Ensure the quality and integrity of the clinical database throughout the study lifecycle.
• Stay current with industry trends and best practices in clinical data management.
• Provide training and guidance to junior data management personnel as needed.

• Bachelor's degree in a life science, computer science, statistics, or a related field.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotech industry.
• In-depth knowledge of EDC systems (e.g., Medidata Rave, Oracle Clinical, Viedoc).
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Experience in database design, data validation, and query management.
• Proficiency in SQL and other database query languages is a strong asset.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong organizational and time management abilities.
• Exceptional written and verbal communication skills, with the ability to effectively communicate technical information.
• Proven ability to work independently and collaboratively in a remote team environment.
• Experience with CDASH and SDTM standards is highly desirable.
• Detail-oriented with a commitment to data accuracy and quality.

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

*Join Our Team as a
Principal Clinical Data Manager - home based in Portugal, Spain, UK or Hybrid in Poland, Sweden.
About This Role
As part of our
CDS Ophthalmology *
team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The
*Principal Clinical Data Manager *
will work independently on preparing, conducting and completing Clinical Data Management tasks on assigned Study Teams according to company policies, SOP's and regulatory requirements.

Key Responsibilities
Responsible for Clinical Data Management activities for assigned studies:

• General mentoring to Clinical Data Managers and Senior Clinical Data Managers on specific Data Management topics as needed
• Act as Lead Clinical Data Manager for assigned data management projects
• Act as a Project Lead for Biometric-only projects
• Coordinate work of other Clinical Data Management staff assigned to the project
• Plan client deliverables and manage project budgets (incl. PFU/revenue files)
• Prepare and distribute periodic project progress reports and oversee preparation of client correspondence
• Coordinate the receipt and processing of information for projects (coding dictionaries, format libraries, and transfer of database specs) as well as electronic data received
• Direct and oversee project-specific initiation and orientation, as necessary, particularly through facilitation of effective kick-off meeting and participation in investigator meetings
• Review Study Protocol
• Develop CRF or review of sponsor-generated CRFs
• Develop Database
• Define and program edit checks
• Responsible to prepare, finalize and archive all related DM documentation
• Develop Data Management Plan and Data Management Report
• Develop Data Validation Plan (including definition of edit checks
• Develop Data Entry Instructions/ eCRF completion guidelines
• Coordinate validation of database, edit checks and trial and site settings
• Performs validation of database, edit checks and trial and site settings in studies where not the responsible CDM
• erform CRF handling including logging, tracking and sorting
• Train and support Clinical Data Associates and Clinical Data Managers
• Support the CRAs in study related questions
• Perform Data cleaning and query handling
• Ensure completion of Quality Control task for the finalization and transfer of the study database and related documents to the sponsor
• May coordinate SDTM mapping with the senior programmer when needed
• Carry out all tasks related to database closure
• Provide CDs with study documentation to the sites (patient data, audit trail and closed queries)
• File/archive essential documents
• Provide metrics and status updates to senior management and project leaders and sponsors if required
• Train and support both internal and external Clinical Study Teams
• Represent TFS Data Management in sponsor and investigator meetings
• Coach, support and mentor of (new) employees
• Responsible to escalate any issues on projects or the need for potential SOP deviations
• Perform system validation, create test scripts for system validation as well as perform UAT of ePROs in collaboration with the CRA
• Actively contribute to the organization and development of processes to enhance the work at TFS
• Provide input into proposals which include Data Management and attend Bid Defense meetings face-to-face or via webex
• File/archive essential documents

Qualifications

• Bachelor's Degree, preferably in life science or nursing, Statistics or Computer Science or equivalent education or equivalent lower education e.g. Associate Degree
• Minimum of 8 years of relevant data management experience, including 5 years as Senior Clinical Data Manager
• Familiarity with medical terminology
• Proven data management skills
• Ability to handle multiple tasks to meet deadlines
• Proven leadership skills
• Excellent English verbal and communication skills
• Ability to deal effectively with sponsors and internal customers
• Ability and willingness to travel on occasion

What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us
Our journey began over 29 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.

• Develop and manage clinical databases, including data validation checks and edit checks.
• Oversee data collection and entry from clinical sites, ensuring adherence to protocols and standards.
• Perform data cleaning activities, identify discrepancies, and resolve data queries in a timely manner.
• Generate data management plans and standard operating procedures (SOPs).
• Ensure compliance with Good Clinical Practice (GCP) and other relevant regulatory guidelines.
• Collaborate with biostatisticians and medical writers to ensure data accuracy for analysis and reporting.
• Manage external data vendors and data transfer agreements.
• Contribute to the design of Case Report Forms (CRFs) and electronic data capture (EDC) systems.
• Prepare and maintain data management documentation.
• Participate in database validation and User Acceptance Testing (UAT).

• Oversee and manage all aspects of clinical data management for assigned clinical trials, from database setup to database lock.
• Develop and maintain clinical data management plans (CDMPs) and standard operating procedures (SOPs).
• Design and validate electronic Case Report Forms (eCRFs) and data capture tools.
• Oversee the creation and execution of data validation plans, including data cleaning and query resolution.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.
• Manage external vendors and databases, ensuring data quality and timelines are met.
• Collaborate with clinical operations, biostatistics, and medical writing teams to ensure data consistency and accuracy.
• Perform data reviews and quality control checks throughout the data management lifecycle.
• Lead database lock activities and prepare final datasets for statistical analysis.
• Train and mentor junior data management personnel.
• Contribute to process improvements and best practices in clinical data management.
• Participate in client meetings to discuss data management strategies and progress.

• Bachelor's degree in a scientific discipline, computer science, or a related field. A Master's degree is a plus.
• Minimum of 7 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proven experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva Vault EDC).
• Strong understanding of clinical trial processes, study designs, and therapeutic areas.
• In-depth knowledge of GCP, ICH guidelines, and data privacy regulations (e.g., GDPR, HIPAA).
• Excellent analytical and problem-solving skills, with meticulous attention to detail.
• Proficiency in database management, data validation, and data reconciliation.
• Strong organizational and project management skills.
• Excellent written and verbal communication skills.
• Ability to work effectively in a team-oriented environment and manage multiple priorities.
• Experience with data standardization (e.g., CDISC SDTM) is highly desirable.

• Oversee the design, development, and implementation of clinical databases in accordance with study protocols and regulatory guidelines (e.g., GCP, ICH).
• Develop data management plans (DMPs), Case Report Forms (CRFs), and electronic data capture (EDC) systems.
• Manage data entry, validation, cleaning, and reconciliation processes to ensure data accuracy and completeness.
• Establish and maintain data standards, including CDISC SDTM and ADaM, for efficient data analysis and reporting.
• Perform data quality checks and queries to identify and resolve data discrepancies in a timely manner.
• Collaborate with clinical operations, biostatistics, programming, and medical teams to ensure seamless data flow and address data-related issues.
• Contribute to the development and validation of data management tools and processes.
• Ensure compliance with all applicable regulatory requirements and company SOPs.
• Manage external data sources and vendor relationships as required.
• Prepare and archive study data management documentation.

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Proficiency with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva Vault EDC).
• Strong understanding of clinical trial processes, data standards (CDISC), and regulatory requirements (GCP, ICH).
• Excellent attention to detail and problem-solving skills.
• Ability to manage multiple projects, prioritize tasks, and meet strict deadlines.
• Effective communication and interpersonal skills, with the ability to collaborate with diverse, remote teams.
• Experience with database design and data validation techniques.

• Oversee and manage all aspects of clinical data management for pharmacovigilance studies, ensuring compliance with global regulatory standards (e.g., FDA, EMA, ICH).
• Develop, implement, and maintain data management plans, data dictionaries, and edit check specifications.
• Lead the design and validation of clinical databases for adverse event reporting.
• Ensure the accuracy, completeness, and consistency of safety data through rigorous data review and query management processes.
• Collaborate closely with pharmacovigilance physicians, safety scientists, and regulatory affairs specialists to interpret safety data.
• Perform data reconciliation activities with external data sources.
• Prepare data for statistical analysis and regulatory submissions.
• Contribute to the development and improvement of data management SOPs and best practices.
• Mentor and guide junior data management personnel.
• Stay current with evolving regulatory requirements and industry best practices in pharmacovigilance and data management.
• Participate in cross-functional team meetings and provide data management expertise.
• Manage relationships with external vendors for data management services if required.

• Bachelor's degree in Life Sciences, Computer Science, or a related field. Master's degree preferred.
• A minimum of 7 years of experience in clinical data management, with at least 3 years focused on pharmacovigilance or drug safety.
• Extensive knowledge of regulatory guidelines for pharmacovigilance (e.g., GVP Modules, CIOMS).
• Proven experience with clinical data management systems (CDMS) and safety databases.
• Strong understanding of data quality assurance principles and methodologies.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to explain technical concepts to non-technical audiences.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Experience in leading data management teams or mentoring junior staff.
• Proficiency in SQL or other database query languages is a strong asset.
• Experience in a remote work environment is highly desirable.
• Commitment to maintaining the highest standards of data integrity and patient confidentiality.

• Lead and oversee all aspects of clinical data management for assigned studies.
• Develop and implement Data Management Plans (DMPs) in accordance with study protocols and regulatory guidelines.
• Design, build, and validate Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
• Develop and execute data validation plans and write data validation checks.
• Manage data cleaning activities, including resolving data queries with clinical sites and study teams.
• Ensure the timely and accurate completion of database lock for clinical studies.
• Collaborate with statisticians and programmers to ensure data integrity for analysis.
• Participate in protocol review meetings to provide data management input.
• Develop and maintain Standard Operating Procedures (SOPs) for data management processes.
• Mentor and train junior clinical data management staff.
• Stay current with industry best practices and regulatory requirements for clinical data management.
• Manage external vendors and CROs involved in data management activities.
• Generate data management reports and metrics.

• Bachelor's degree in a scientific, medical, or technical field; Master's degree preferred.
• Minimum of 5-7 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Extensive experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva EDC).
• Strong understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Proficiency in developing DMPs, data validation plans, and edit check specifications.
• Experience with database lock procedures.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to interact effectively with global teams.
• Proven leadership and mentoring abilities.
• Demonstrated ability to manage multiple projects and prioritize tasks effectively in a remote environment.
• Experience with data standardization (e.g., CDISC SDTM, ADaM) is a significant plus.
• Proficiency in MS Office Suite, particularly Excel.