Sr.Clinical Data Manager Job at Katalyst Healthcares & Life Sciences, East Windsor, Mercer County, NJ

S3lUNnZVRy8veGF0Q0lNV1lRWGNVQWE1b0E9PQ==
  • Katalyst Healthcares & Life Sciences
  • East Windsor, Mercer County, NJ

Job Description

Responsibilities:

Act as the point of contact for DM activities for the assigned clinical studies and proactively provide DM expertise to both internal and CRO cross-functional teams.

Assist the head of data management in establishing standards for electronic Case Report Forms (eCRFs), edit checks, data listings and reports, and data metrics.

Supervise and ensure all databases are developed, validated and ready for production release according to both Structure and CRO SOPs and working instruction.

Facilitate database design by the CRO according to the protocol and also in line with Structure global standard library; lead and perform sponsor acceptance testing of the clinical database.

Contribute to the development/review of all the DM documentations, including but not limited to CRFs, CRF completion guidelines, Data Management Plan, Edit Check Specification, Data Review Plan, Data Transfer Specifications, etc.

Ensure the oversight activities are conducted by the internal study teams as specified in the study specific Data Quality Oversight (DQOP), and the observations are Plan documented on the study specific cumulative Data Issue Tracker, and the confirmation of resolution are properly documented.

Participate in development of DM specific SOPs.

Core Competencies, Knowledge, and Skill Requirements.

Detail-oriented, thorough and well-organized.

In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, 21CFR Part 11and ICH guidelines.

Requirements:

BS/MS in Life Sciences, Informatics, Computer Sciences, or related fields.

8+ years of clinical data management experience in pharmaceutical and/or CRO's

Complex and international trial experience desired.

Strong communication (written and oral), decision-making, influencing, and negotiation skills at all organizational levels.

Ability to work independently and effectively in a fast-paced and collaborative environment.

Proficient in Medidata Rave and/or other EDC platform study builds and operation

Experience working with and managing CROs/external vendors, 5+ years preferred

Experience with regulatory inspection/audit preparation preferred..

Job Tags

Permanent employment,

Similar Jobs

Futurex

Lead Technical Content Writer Job at Futurex

 ...creativity and collaboration, making us a powerhouse of ideas and solutions.Role Overview:We are seeking a talented Lead Technical Content Writer to join our Documentation team. As a Lead Technical Content Writer at Futurex, this individual will be responsible for the... 

SSD Alarm

Operations Manager for Fire Alarm and Security - Culver City Job at SSD Alarm

 ...Job Details Level Management Job Location Culver City Branch - Culver City, CA Position Type Full Time Salary Range $120,000.00 - $180,000.00 Salary/year Job Shift Day Job Category Management Description With over 50 years in the... 

Nexus Wines

Wine Consultant Job at Nexus Wines

 ...patiently listen to their needs, and provide professional and detailed wine knowledge answers.By communicating with customers,...  ...attention to the dynamics and latest research results of the wine industry, and continuously improve one's wine knowledge level.Participate... 

Union Transport Corp.

Freight forwarder assistant Job at Union Transport Corp.

 ...another country,please contact your Human Resource representative to discuss the process and requirements of applying. Job area: Freight Forwarding FRAUD ALERT: Please note that DSV will never request a chat interview or solicit funds from applicants or employees through... 

Headway

Licensed Clinical Social Worker Job at Headway

 ...clients you see through Headway, so that you can set the hours that work for you. Grow your caseload by providing marketing support and...  ...patients in-person or remotely via telehealth while working from home. We accept the following licenses on a state by state basis:...