Clinical Data Manager

From formulation development through global clinical trials to final approval, Symbio provides specialized experience and expertise in clinical research. Our global studies have helped pave the way to advancements in Dermatology, Inflammatory Disease, Aesthetics, Rare Disease, Medical Device and Gastroenterology.

We are currently seeking a full-time Clinical Data Manager to join our team. This position is a remote, work from home opportunity.

In this role, you will oversee data management activities and serve as the main point of contact for clinical trials in a variety of therapeutic areas. You will be responsible for the day-to-day activities for assigned studies and data scenarios, as well as collaborate and communicate with study team members and provide study metrics to team members.

Key Responsibilities:

• Responsible for coordination of data management activities and study specific training on assigned studies.
• Act as liaison for Project Management, Statistics, Monitoring, and other Data Management staff for specific study activities including timelines, correspondence, and data trends.
• Provide review of draft protocols, protocol amendments, project management plans, etc.
• Represent Data Management during sponsor conference calls, webinars, and off-site training meetings, as needed.
• Create and/or reviews all related Data Management documents, including DMP, (e)CCGs, (e)CRFs, DTAs, PV/PD logs, DVPs, etc.
• Support Data Management staff as needed for in-depth clinical data review of study patient information to ensure complete and accurate data for analysis and protocol compliance.
• Responsible for overseeing and/or reviewing medical coding in coordination with Medical Affairs.
• Responsible for coordination of quality assurance activities and completion of quality assurance summaries prior to database lock.
• Provide training for Data Management support staff.
• Provide database content review/UAT testing, as needed.
• Responsible for pre-lock, database lock, and post-lock activities.

Ideal Candidate Qualifications:

• Bachelor’s degree, preferred.
• 3+ years of in-depth medical terminology experience.
• 3+ years of experience in a data intensive/reconciliation type environment.
• 2+ years of experience in pharmaceutical industry or equivalent industry experience.
• Demonstrated experience with the following: SAS, RTSM (Randomization and Trial Supply Management) also known as IRT (IWRS/IVRS), Vendor Data Transfers/Reconciliation, and MedDRA/WHO Drug Dictionaries.
• Strong organizational, analytical, and problem-solving capabilities.
• Ability to work independently and in a team-oriented collaborative environment.
• Ability to learn, understand, implement, and apply new technologies, concepts, and/or processes.
• Ability to effectively prioritize and execute tasks in a high-pressure environment with a sense of urgency.
• Ability to communicate effectively in a verbal and written form to a variety of stakeholders.

Why Symbio? We offer a collaborative, flexible environment where your contributions directly impact our success. If you have the expertise and passion for clinical data management and want to be part of a dynamic team advancing clinical research, we would love to review your CV and discuss this opportunity further.

Please submit your CV and cover letter to Jennifer Kidd at [email protected].

From formulation development through global clinical trials to final approval, Symbio provides specialized experience and expertise in clinical research. Our global studies have helped pave the way to advancements in Dermatology, Inflammatory Disease, Aesthetics, Rare Disease, Medical Device and Gastroenterology.

We are currently seeking a full-time Clinical Data Manager to join our team. This position is a remote, work from home opportunity.

In this role, you will oversee data management activities and serve as the main point of contact for clinical trials in a variety of therapeutic areas. You will be responsible for the day-to-day activities for assigned studies and data scenarios, as well as collaborate and communicate with study team members and provide study metrics to team members.

Key Responsibilities:

• Responsible for coordination of data management activities and study specific training on assigned studies.
• Act as liaison for Project Management, Statistics, Monitoring, and other Data Management staff for specific study activities including timelines, correspondence, and data trends.
• Provide review of draft protocols, protocol amendments, project management plans, etc.
• Represent Data Management during sponsor conference calls, webinars, and off-site training meetings, as needed.
• Create and/or reviews all related Data Management documents, including DMP, (e)CCGs, (e)CRFs, DTAs, PV/PD logs, DVPs, etc.
• Support Data Management staff as needed for in-depth clinical data review of study patient information to ensure complete and accurate data for analysis and protocol compliance.
• Responsible for overseeing and/or reviewing medical coding in coordination with Medical Affairs.
• Responsible for coordination of quality assurance activities and completion of quality assurance summaries prior to database lock.
• Provide training for Data Management support staff.
• Provide database content review/UAT testing, as needed.
• Responsible for pre-lock, database lock, and post-lock activities.

Ideal Candidate Qualifications:

• Bachelor’s degree, preferred.
• 3+ years of in-depth medical terminology experience.
• 3+ years of experience in a data intensive/reconciliation type environment.
• 2+ years of experience in pharmaceutical industry or equivalent industry experience.
• Demonstrated experience with the following: SAS, RTSM (Randomization and Trial Supply Management) also known as IRT (IWRS/IVRS), Vendor Data Transfers/Reconciliation, and MedDRA/WHO Drug Dictionaries.
• Strong organizational, analytical, and problem-solving capabilities.
• Ability to work independently and in a team-oriented collaborative environment.
• Ability to learn, understand, implement, and apply new technologies, concepts, and/or processes.
• Ability to effectively prioritize and execute tasks in a high-pressure environment with a sense of urgency.
• Ability to communicate effectively in a verbal and written form to a variety of stakeholders.

Why Symbio? We offer a collaborative, flexible environment where your contributions directly impact our success. If you have the expertise and passion for clinical data management and want to be part of a dynamic team advancing clinical research, we would love to review your CV and discuss this opportunity further.

Please submit your CV and cover letter to Jennifer Kidd at [email protected].