Job Summary
We are seeking a highly experienced General Manager for our Clinical Data Management and Pharmacovigilance (CDM/PV) team. The ideal candidate will have 13 to 16 years of experience with mandatory expertise in MS Excel. A background in Research and Development is a plus. This hybrid role requires no travel and operates during day shifts.
Responsibilities
Oversee the daily operations of the CDM/PV team to ensure data integrity and compliance with regulatory standards.Lead the development and implementation of data management strategies to support clinical trials and pharmacovigilance activities.Provide guidance and support to team members in the use of MS Excel for data analysis and reporting.Ensure timely and accurate data entry validation and quality control processes.Collaborate with cross-functional teams to align data management practices with overall project goals.Monitor and report on key performance indicators to track the effectiveness of data management processes.Develop and maintain standard operating procedures for data management and pharmacovigilance activities.Conduct regular training sessions to enhance the technical skills of team members.Facilitate communication between the CDM/PV team and other departments to ensure seamless project execution.Implement best practices for data security and confidentiality.Provide expert advice on data management and pharmacovigilance issues to senior management.Drive continuous improvement initiatives to enhance the efficiency and effectiveness of data management processes.Ensure compliance with all relevant regulatory requirements and industry standards.
Qualifications
Possess extensive experience in MS Excel including advanced functions and data analysis techniques.Demonstrate a strong understanding of clinical data management and pharmacovigilance principles.Have a background in Research and Development which is considered an asset.Exhibit excellent organizational and time management skills.Show proficiency in developing and implementing standard operating procedures.Display strong leadership and team management capabilities.Possess excellent communication and interpersonal skills.Demonstrate the ability to work effectively in a hybrid work model.Show a commitment to maintaining data integrity and confidentiality.Have experience in training and mentoring team members.Exhibit a proactive approach to problem-solving and continuous improvement.Demonstrate the ability to collaborate effectively with cross-functional teams.Show a strong commitment to regulatory compliance and industry standards.
Certifications Required
Certified Clinical Data Manager (CCDM) Advanced Excel Certification
