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Manager, Data Management & Report Writing

Manager, Data Management & Report Writing

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• Manage the scope of work, objectives, timelines, quality of deliverables, and all other activities of the business unit
• Oversee data transfer process lifecycle; including template set-up, test data generation and execution, addressing QA audits, and submission of data to clients
• Oversee the execution and provide support for study data transfer activities, database set-up, sample reconciliation, data compilation, and data formatting
• Ensure delivery of high-quality scientific reports that meet industry standards
• Manage performance and professional development of staff
• Provide guidance and decision-making on scientific, operational, and regulatory issues, as appropriate
• Present improvement strategies to clients and/or Management
• Oversee resource and capacity planning
• Work alongside senior colleagues to define strategies for business success and growth
• Establish Key Performance Indicators to identify opportunities for improvement
• Participate in client and regulatory audits as required
• Implement programs and drive process improvement
• Oversee staff recruitment, training, and progression
• Ensure employee adherence to regulatory compliance for data integrity and assigned SOPs
• Review and author SOPs, as appropriate
• Other tasks as assigned
• Education, Skills and Qualifications
• BA/BS or higher with 10+ years management experience; all experiences will be evaluated
• Strong knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
• Able to mentor and develop staff
• Able to work in a regulated environment
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to communicate clearly
• Experience in a regulatory environment
  
  
  

Job Description

Job Responsibilities

• Manage the scope of work, objectives, timelines, quality of deliverables, and all other activities of the business unit
• Oversee data transfer process lifecycle; including template set-up, test data generation and execution, addressing QA audits, and submission of data to clients
• Oversee the execution and provide support for study data transfer activities, database set-up, sample reconciliation, data compilation, and data formatting
• Ensure delivery of high-quality scientific reports that meet industry standards
• Manage performance and professional development of staff
• Provide guidance and decision-making on scientific, operational, and regulatory issues, as appropriate
• Present improvement strategies to clients and/or Management
• Establish group/team objectives
• Oversee resource and capacity planning
• Work alongside senior colleagues to define strategies for business success and growth
• Establish Key Performance Indicators to identify opportunities for improvement
• Participate in client and regulatory audits as required
• Implement programs and drive process improvement
• Oversee staff recruitment, training, and progression
• Ensure employee adherence to regulatory compliance for data integrity and assigned SOPs
• Review and author SOPs, as appropriate
• Other tasks as assigned
• Education, Skills and Qualifications
• BA/BS or higher with 10+ years management experience; all experiences will be evaluated
• Strong knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
• Able to mentor and develop staff
• Able to work in a regulated environment
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document clearly
• Able to communicate clearly
• Experience in a regulatory environment
  
  
  

About Us

Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.

We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.

If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Information Technology

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