Senior Clinical Data Manager, Neurovascular

vmysmartpros; India; On-site; INR 7,690,617 - 13,183,915; Full time

Job summary

Johnson & Johnson is seeking a Senior Clinical Data Manager for EMEA-region projects, focusing on data cleaning, quality review, and high data integrity across trials.

The role reports to Data Management leadership and requires experience in clinical data management within Medical Device or Pharmaceuticals environments.

Qualifications

• Therapeutic area knowledge in orthopedics, gynecology, cardiovascular or general surgery.
• Proficient in computer systems related to data management.

Responsibilities

• Support data management activities from protocol initiation to database lock.
• Oversee data cleaning and QC to ensure data integrity and timelines.
• Coordinate with CROs and internal teams to manage data flow.
• Develop data management plans and documentation as needed.

Skills

Clinical data management

GCP knowledge

Biological sciences background

Data quality control

Education

Bachelor's degree in Biological sciences or CS

Job description

Job Description

SENIOR CLINICAL DATA MANAGER, NEUROVASCULAR

Location: Belgium, France, Germany or Poland

(However applications open to the entire EMEA region)

Contract: full-time

(MedTech)

(Data Analytics & Computational Sciences)

(Clinical Data Management)

The Senior Clinical Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. Reporting to the Manager, Data Management.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area if required;
• Have the ability to support a number of moderate complexity / complex trials with minimal supervision;
• Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight;
• Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines;
• Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;
• Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project;
• Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;
• Be responsible for handling of non-CRF data, including lab data and image handling;
• Be responsible for co-ordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;
• Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed;
• Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;
• Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;
• Diligently participate in compliance program-related activities as denoted by the supervisor or our Chief Compliance Officer;
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

• A Bachelors degree (or equivalent) in the biological sciences, Computer Science or related discipline, with at least 4 years of clinical data management experience in Medical Device or Pharmaceuticals.
• Experience of supporting trials with minimal supervision.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Functional and Technical Competencies:Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.
• Proficient in computer .