SENIOR CLINICAL DATA MANAGER

SENIOR CLINICAL DATA MANAGER

JOB DESCRIPTION / SUMMARY

The Senior Clinical Data Manager (Sr. CDM) is responsible for data management

activities across multiple studies. The Sr. CDM will report to the Manager, Clinical

Data Management and will work closely with a cross-functional team in a fast-paced

environment.

The Sr. CDM is responsible for leading the end-to-end data management activities

and associated deliverables for clinical trials including study set-up, conduct and

close-out, standards development and GCP compliance.

RESPONSIBILITIES

This is a direct, hands-on role and the main requirement is to perform, as well as

manage, all day-to-day data management activities. Other responsibilities include,

but are not limited to:

• Create, review and approve all data management study-related documents,

which may include, but not limited to: eCRF/Database specifications, Edit Check

specifications, Data Management Plan (DMP), UAT Plan Data Review Plan (DRP),

CRF Completion guidelines, Coding Convention guidelines and other

documentation as required.

• Perform and manage all data cleaning activities including processing queries,

performing ongoing data review, and orchestrating scheduled cross-functional

data review/reconciliation, identifying issues, data trends and tracking them

through resolution.

• Perform and manage all database build activities, database validation and review

and execution of User Acceptance Testing (UAT).

• Represent Data Management in internal study team, client and CRO meetings.
• Actively review and provide feedback on study data quality including providing

data management metrics, review project statement of work and identify and

report to manager any requested out of scope activities.

• Work with outside vendors (such as safety laboratories, cardiac laboratories) to

develop data transfer documents and perform regular data reconciliation with

the clinical database.

• Assist DM oversight role/manager in monitoring timelines and managing

resources to meet timelines.

Senior Clinical Data Manager Job Description

• Identify inconsistencies and inefficiencies in data management processes and

recommend solutions.

• Have a thorough understanding of the study billing guide, manage expectations

with the support Clinical Data Manager(s) on the assigned tasks, available hours,

and keep the billing guide current.

o Forecast hours available against study activities and

o Assess if the study activities are in scope per the approved budget

o Work with the DM oversight role/manager in the change order process and

ensure an approved change order is in place for any out-of-scope work.

• Enter and verify the time spent on project and non-project work on InClin's time

tracking tool regularly (daily time entries preferred, weekly at the minimum).

• Direct team members in daily activities including training and supervising study

support staff.

KNOWLEDGE & SKILL REQUIREMENTS

• 9+ years data management experience and B.S./B.A. in a science or technical

discipline degree.

• Previous CRO experience is strongly recommended.
• Proficient in MS Excel.
• Ability to program in SQL or SAS desirable, but not required.
• Experience with various data collection and Electronic Data Capture (EDC)

systems and related tools and processes. Medidata Rave EDC, Medrio eClinical

and Clario EDC experience are preferred, but not required.

• Excellent oral and written communication skills.
• Ability to work in a collaborative and multi-disciplinary environment.
• Attention to detail, ability to prioritize and manage multiple projects with

competing and aggressive timelines.

• Availability to travel for clinical team meetings and/or Investigator Meetings if

needed.

• Good knowledge of Food and Drug Administration (FDA), Europe Medicines

Association (EMA), International Conference on Harmonisation (ICH) guidelines

and Good Clinical Practices (GCPs) including regulatory requirements for the

conduct of clinical development programs, especially as related to data handling

and processing.