Data Manager or Supervisor-SH
Under the direction of the applicable management, the Senior Clinical Data Manager (SCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
Primary activities include, but are not limited to:
§ All responsibilities of a Clinical Data Manager.
§ Assume data management responsibilities for larger, more complex or higher priority protocols.
§ May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines, and provide data entry status to the Clinical Development Scientist (CDS).
§ Provide protocol specific training of SDE Process to CDM.
§ Triage, research, discuss and resolve the reports outputs provided by Clinical Development Scientist (CDS) and Statisticians at a protocol level during in-life and database lock stages supported by the LCDM.
§ Supports the LCDM in the preparation, creation and review of data management tool specifications and tools
§ Participates in User Acceptance Testing (UAT) of the Clinical Database Repository under the direction of the LCDM.
§ Coordinates communications, global status tracking and issue resolution at study level with Lead CDM (LCDM).
§ Responsible for the communication with Clinical Trial Operations team regarding site level issues on protocol a basis on behalf of the LCDM.
§ Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to LCDM.
§ Responsible for study level status assessment, reporting and communication with LCDM.
§ Complete trial level archiving activities under the direction of the LCDM including, but not limited to, filing of essential documentation.
§ Coordinate and mentor CDMs and other SCDMs who work in his/ her protocol to ensure their compliance with SOPs, data management plans and data review plans.
§ Be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as providing inputs to create or update SOPs, supporting documents and training materials as needed.
§ May be required to support DMC Process Owner (PO) Models in the local DMC and/or in the Global PO networks.
§ Participate in cross functional technical or process improvement projects.
Manual Encoding Lead
§ Perform all responsibilities of a Manual Encoder under the Clinical Data Manager.
§ Ensure encoding accuracy and consistency across all protocols within a project.
§ Works closely with DMC manual encoders and Data Management Trial Manager (DMTM) to ensure all encoding tasks are completed prior to interim analysis, frozen files/ database locks.
§ Serves as Subject Matter Expert (SME) for encoding documents and processes.
§ Responsible to review specified therapeutic area encoding as requested.
§ Coordinates with LCDM to create and review encoding specifications documents and performs User Acceptance Testing (UAT) of coding application (s).
§ Responsible for encoding external partner data as applicable and consultant for Contract Research Organization (CRO) partners.
§ Runs encoding check reports in accordance with data review plans to identify encoding issues.
§ Raises questions with investigational site staff or DMC manual encoders and reviews responses and corresponding data corrections to confirm resolution.
§ Responsible for study level encoding status reporting and assessment, and communication with DMC Clinical Trial (CT) management during in-life data management activities and preparation for database lock.
At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Knowledge and Skills:
Two years’ experience in clinical data management in pharmaceutical or health care clinical research environment is preferable.
Self-motivated, excellent in work planning and time management.
Fluent oral and written English skills.
Good basic awareness of the clinical development process.
Good basic awareness of clinical practice and grasp of medical terminology.
Good sense and awareness of regulations and policies.
Able to work under pressure and in a changing environment with flexibility.
Good communication skills with the ability to communicate with both technical and business areas.
Proven leadership skills, specifically the ability to coordinate the work of others and influence management on decision making