Senior Clinical Data Analyst

Job Purpose:

The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. Further responsibilities shall include providing technical expertise and/or operational leadership regarding all DM operational activities (data cleaning matrices), processes and Data Management documents regarding data validation. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

 SCDA acts as a subject matter expert on DM Systems/processes, providing technical support and expert advice to internal and external sponsors.

The SCDA may act as a back-up to or fulfill the Data Management Lead role where required.

Key Accountabilities:

Accountability

Data Validation (cleaning)

• Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.g. query management, manual/SAS listing reviews and external vendor data reconciliation.

• Highlight issues/risks to delivery by understanding interdependencies - support mitigations as part of Risk Management Plan.

Data Management Documents/Plans (Trial Master File)

• Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.

Study Start-Up Activities and User Acceptance Testing (UAT)

• Lead/perform user acceptance testing on clinical database setups.

• Review protocols and EDC Entry Screens if required.

 • Provide input on and tracking the data management timelines and coordinate the DM operational activities during database set up, up to project close out.

Data Tracking and Entry

• Track and review CRFs. Support data entry where required

• Project Quality Management & Compliance

• Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.

 • Perform/Lead functional QC activities on databases and/or patient data, as per business needs.

Skills:

• Minimum of 7+yrs of experience in Clinical data management or a related field.

• Proven ability to lead and collaborate with global and cross-functional teams - ability to coordinate & prioritize tasks for the DM operational and programming teams (when) in the Primary CDA role.

• Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed.

• Proven negotiation skills and ability to influence in order to achieve mutually beneficial results.

 • Strong problem-solving skills and logical reasoning, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses.

• Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail).

 • Proven Time management and prioritization skills with a strong sense of urgency - in order to meet objectives.

• Advanced interpersonal, oral and written communication skills - using concise phrasing tailored for the audience with a diplomatic approach.

• Good presentation skills.

• Proven learning ability and knowledge sharing approach; swift understanding of technologies and new processes.

• A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments.