Siro Clinpharm - Associate Manager - Clinical Data Management

Key Accountabilities:

- Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (Standard Operating Procedures) and processes. These activities may include the following categories:

Data Review:

May perform one or more of the following:

- Performs data review of clinical trial data, including query management. Communicates with study team members and CRO (Contract Research Organization) to resolve queries.

- Performs detailed review of eCOA/external data per the Data Review Plan and works closely with the vendor and CRO to resolve eCOA/external data-related issues. May include the following:

Acts as liaison:

- Performs reconciliation review of eCOA/external data against EDC (Electronic Data Capture) data and works with applicable parties to resolve queries.

- Performs SAE (Serious Adverse Event) reconciliation and communicates with applicable safety team members to resolve issues.

- May prepare and distribute performance metrics (e.g., site completion of data entry and resolution of queries) to applicable stakeholders. Escalates to CDM Lead and study team as needed.

Contributes to the creation and maintenance of study data cleaning plan components, including:

- Edit checks (data validation plan)

Listing review checks

- Data integration specifications

- Data transfer specifications

- External data reconciliation plan(s)

- Coding guidelines

- SAE reconciliation guidelines

- Database lock plans

- Performs additional review activities for interim and final database locks as needed.

- Documentation & Filing:

- Files study documentation in electronic Trial Master File (eTMF) and department project files.

- Performs periodic quality review of eTMF documents.

- Assists with taking meeting minutes and documenting/tracking study data management activities.

- Performs data archival activities.

- Performs inspection readiness activities and supports the CDM team during internal and regulatory inspections.

Data Collection Systems

Supports the set-up and testing of study data collection tools such as:

- EDC (Electronic Data Capture)

- IRT (Interactive Response Technology)

- eCOA (Electronic Clinical Outcome Assessment)

- ePRO (Electronic Patient-Reported Outcomes)

- Creation/maintenance of associated documentation

- May contribute to the creation and maintenance of study eCRF (electronic Case Report Form)

- Completion Guidelines and other data collection tool guidelines.

- May assist with management of account access and training materials for data collection tools.

Additional Activities:

- Assists with quality review of activities performed by the CRO, as needed.

- Coordinates and oversees the work of other data coordinators.

- Mentors other data coordinators.

- Ensures compliance with own Learning Curricula, corporate, and/or GXP requirements.

- Performs other duties as assigned.

Educational Qualifications & Experience:

Education:

- Bachelors degree in a relevant field preferred.

Experience:

- Understanding of clinical trial documents (protocols, case report forms, data management plans, study reports) and processes.

- Preferred 2-5 years of relevant work experience or an equivalent combination of training and experience.

- Preferred experience in data management/drug development within a GCP/clinical research regulatory environment.

- Experience with electronic data collection systems.

- Experience managing multiple work deliverables and deadlines.

- Knowledge of data management best practices & technologies as applied to clinical trials.

- Knowledge of FDA and ICH regulations and industry standards applicable to data capture and data

management processes.