Clinical Data Manager / Senior Clinical Data Administrator

Job Description

Clinical Data Manager / Senior Clinical Data Administrator

• REMOTE, USA
• Full-time permanent position
• A competitive annual salary, health and medical insurance, vacation, IRA retirement plan, DPSP.

Are you passionate about data management? Do you thrive in a dynamic clinical research environment, and are eager to work with a talented team? Are you excited about working on cutting-edge technology? If you’re up for a new and exciting challenge, with a company that offers a chance to have fun while you work, look no further.

We’re , and we’ve joined forces with our client, a full-service clinical research organization. For over 30 years they are providing successful clinical trials for the medical device, biotechnology and pharmaceutical industries.

What you’ll be doing :

As a Clinical Data Manager, you’ll be reporting to the a and playing an important role in the overall company operation. This position is responsible for study data management and working effectively with clinicians, allied healthcare personnel, clients, vendors, and internal staff.

The best in this role are people who can wear multiple hats and who have a blend of both strong database and data management skills and who have a growth mindset. To be successful in this role, you must be self-motivated, well-organized, proactive, collaborative, and adaptable.

Practically speaking, you will :

Interface with clinical Project Manager(s) and statistician(s) to establish project data management plans and requirements, and database implementation schedules and other key study documents

Interface with IT Manager, Project Manager, and Software Developer to review project database implementation schedules, database utilization training, and database utilization efficiency

Participate in the department project clinical data system design, utilization, and maintenance to maintain conformance with FDA guidelines for clinical data management

Review protocols for CRF design and creation and develop electronic CRFs for use in clinical data management systems

Develop and maintain data management documentation including : Data Management Plan, Database Development Specifications with Edit Check Specifications, Data Review Guidelines, and other Data Management Specific documents

Create and develop database specification documentation for database programming according to CRF

Collaborate with biostatisticians in the creation of analysis datasets

Program and develop database in accordance with database specification and CRF documentation

Modify database to accommodate any requested database updates or modifications

Program and generate reports within database as requested by sponsor and / or project team

Create test data and perform user acceptance testing on new databases

Complete ongoing data review activities for assigned study and provided feedback to study teams

Coordinate with Coder or complete coding activities throughout the study

Coordinate with external vendors as needed for assigned study

Perform database quality assurance audits and database locks

Establish and maintain department Standard Operating Procedures for data management activities. Work with Quality Systems Manager and / or Administrator to revise, develop, or implement new procedures as required

Provide recommendations for improvement of project or divisional efficiencies based on work experience and observations

Participate in project review meetings as requested

Participate in business development proposal team and presentations as needed

Participate in budget maintenance for project data management-related activities

The Details

This is a full-time permanent REMOTE position based in any locations across USA. The head office is in Costa Mesa, CA USA. There will be light travel required for this role, to attend client / vendor meetings and customers. In addition to a competitive base salary in the range of $90,000 -$150,000 (commensurate with experience), you’ll enjoy a robust benefits package and vacation.

Skills and Qualifications

BS or BA degree

5+ years experience in data management

Ophthalmology experience

Proficiency in Data Management Plan development and maintenance

ePRO experience

Proficiency in EDC systems (including Medrio and Medidata Rave) with database development, query management, reports generation and associated database specification documentation

Database build experience, including experience with programming and database set up within Medrio and other EDC systems

Experience with study start up tasks, CRF design, database development, edit check creation, eCRF completion guidelines, validation and user acceptance testing

Thorough understanding of FDA, ICH and GCP regulations and guidelines regarding management of data for clinical studies

Familiarity with current data standards (e.g., XML / CDISC) and database administration

Knowledge of programming in SQL reporting using Microsoft SQL Reporting Services and Crystal Reports desirable

Understanding of coding process and dictionaries

SAE Reconciliation and external data reconciliation experience

Strong communication skills as demonstrated via telephone interactions, personal presentations, and general written correspondence.

Well-organized, with strong attention to detail, documentation, and follow-through. Ability to work on multiple tasks simultaneously.

Leadership skills, and ability to work effectively within a team configuration

Willingness to both lead studies as data manager and complete ongoing data management review from start up through database lock for assigned studies

Pharma and medical device experience preferred.

Your Application

We value diversity and inclusion and encourage all qualified people to apply; however, only those selected for an interview will be contacted.