Clinical Data Manager III (CDM III)

Caidya; India; Hybrid; INR 900,000 - 1,200,000; Full time

Job summary

Caidya is seeking a Clinical Data Manager III to contribute to data management activities on multiple projects. Based in India with remote options, you will manage CRF/eCRF data, external data reconciliation, SAE reconciliation, and support database close/lock procedures in line with GCP/ICH and sponsor requirements.

You will act as a project POC, allocate work, supervise junior team members, maintain high data quality, and participate in audits and process improvements while adhering to

Qualifications

• College graduate with a degree in life science, computing or nursing qualifications preferred; or 3 to 4 years equivalent experience.
• Minimum of 5 years of experience in data management; international team experience preferred.
• Experience in pharmaceutical/CRO industry; prior trial responsibility for data management lifecycle.
• Working knowledge of EDC studies; strong organizational and communication skills.

Responsibilities

• Participate in clinical data management activities for trials per SOPs and GCP/ICH.
• Develop data management guidelines and study documentation (DMP, DVP, CRF guidelines).
• Lead data management tasks: CRF design review, data listings, query generation, data reconciliation.
• Support database close/lock procedures and archiving of documents; act as PM/POC on projects.

Skills

Data management

Regulatory knowledge

Communication skills

Problem solving

Education

Bachelor's degree in life science / computing / nursing or equivalent

Tools

EDC systems

Microsoft Office

Clinical data management systems

Job description

Home/Office Based Either: Home or Office Based

Job Title: Clinical Data Manager III (CDM III)

Job Location: India (Remote)

Job Overview:

The Clinical Data Manager III is responsible to participate the clinical data management activities for a project within a data management team; including processing of Case Report form and electronic data, processing and reconciliation of external data, SAE reconciliation and supporting the database close/lock procedures in accordance with Caidya SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements. Work as a Project Point of Contact (POC), manage work allocation and work with minimal or no supervision.

Job Duties and Responsibilities:

The specific job duties of a Clinical Data Manager III may include but are not limited to:

For specified projects performs start-up activities including:

• Developing data management guidelines and study documentation
• Review of CRF design against protocol
• Lead study developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation. Activities include design, database structure, document creation; including approval

For specified projects performs data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.

• Study status tracking
• Review of data listings
• Identification of data issues and query generation
• Updating of database with query resolutions (paper studies only)
• Processing and reconciliation of external data including SAE reconciliation
• Ownership and proactive management of the data reconciliation activities documented in the DVP, DMP, etc.
• Provide input for Database closeout and lock activities and timelines
• Archiving of critical documents on an ongoing basis
• If assigned the Lead Data Manager role, act as key data management contact for the project.
• Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
• Proactively manage project quality through supervision and quality control of team members’ work.
• Proactive participation in appropriate sponsor/project team meetings.
• Active involvement in departmental and organizational meetings and initiatives.
• Develops and documents departmental procedures.
• Training and Mentoring of team members in accordance with established departmental procedures.
• Supports and tracks budget adherence in cooperation with Finance to ensure the assigned studies are meeting targeted margins and utilization
• Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology and incorporating innovation to optimize delivery
• Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure Caidya DM procedures are in line with industry expectations
• Indirect supervision of the work of junior members of the project team.
• Other duties as assigned

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

Education

• College graduate with a degree in life science, computing or nursing qualifications preferred; or 3 to 4 years equivalent experience.

Experience

• Minimum of 5 years of experience and/or demonstrated aptitude for data management work. International team experience preferred.
• Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
• Prior trial responsibility for entire data management life-cycle
• Working knowledge of EDC studies
• Excellent organizational skills
• Strong written and verbal communication skills
• Exceptional attention to detail
• Knowledge of clinical research including regulatory requirements GCP/ICH
• Strong interpersonal skills; serve as the point of contact for data management activities
• Strong computer skills, including Microsoft Office and clinical data management systems
• Demonstrated problem-solving skills

Capabilities

• Flexibility - willing to change assignments and work focus to accommodate project demands
• Team player – effective proactive participant as a team member.

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The company will not accept unsolicited resumes from third party vendors.