TWO CLINICAL DATA MANAGERS NEEDED

***Top Pharmaceutical Company Seeks Data Manager***

 

Location: Lawrenceville, New JerseyObjectives

Define, manage and execute the data management process for quality and timely delivery of clinical trial/compound data.

 Accountabilities:

¨ Independently manage all data management tasks for assigned clinical trials and compounds (drug projects), including interactions with internal and external customers:

-  Develop and/or review data management plans

-  Coordinate and approve development and printing of case report forms

-  Coordinate database setup including edit checks and testing

-  Coordinate non-CRF data collection and format

-  Coordinate database lock activities

-  Coordinate review and feedback process for data transfers and data listings

-  Provide accurate deliverables within timelines established by the study team and project team

-  Review clinical trial documents (e.g., protocols, case report forms, statistical analysis plans, study reports)

¨ Monitor data processing activities (collection, entry, queries, coding) to ensure quality and timely processing of clinical trial data

¨ Define and maintain specifications for study and project level database/CRF and data management processes ensuring compliance with company-wide and project level standards

¨ Complete task designations for vendors via Scope Worksheet and Task Order process; assist in CRO evaluation, selection and management of vendors.

¨ Represent data management at Investigator Meetings, CRO Meetings and internal team meetings (responsible for presentations and information exchange)

¨ Assist in mentoring and training department staff

¨ Assist in evaluation, implementation and testing of internal systems

¨ Comply with all applicable regulatory requirements and Company standards and procedures, including documentation of data management activities and archival of study documentation.

 Knowledge:

¨ Intermediate knowledge of relational databases and common clinical data management systems

¨ General knowledge of SAS programming

¨ Advanced knowledge of office software (Microsoft OfficeÒ).

¨ Strong understanding of clinical trial documents (protocols, statistical analysis plans, CRF’s, study reports) and processes

¨ Good understanding of drug development process

¨ Good knowledge of FDA and ICH regulations and industry standards and quality assurance principles

¨ Intermediate knowledge of medical terminology, laboratory data and disease processes

 Competencies:

The following are examples of technical and behavioral competencies that are required to achieve the objectives of this position.

 Functional/Technical

¨ Ability to read and understand protocol requirements for accurate case report form design

¨ Ability to define an efficient data validation plan to ensure quality data

¨ Ability to define and implement an efficient data review process 

¨ Ability to clearly and fully document data management processes and decisions throughout the duration of the trial.

¨ Ability to utilize common data management and office software

¨ Ability to understand medical terminology Strategic Approach

¨ Effectively collaborates with the study/project teams to plan, execute and report on clinical trials 

¨ Proactively identifies needs, potential conflicts and solutions to the team related to data management. Working Relationships

¨ Actively seeks input in planning and execution of data management processes from clinical, statistics and other members of study teams

¨ Productively collaborates with CRO when providing guidance for data management activities

¨ Effectively participates in team meetings.  Seeks input and prepares prior to meetings; raises issues and proposes solutions; provides timely communication of meeting outcomes and follow-up.

¨ Strong oral and written communication skills. Effectively communicates information, including the feasibility for data management tasks, to the teams. 

¨ Effectively communicates within appropriate levels of the organization

Managing Change

¨ Actively follows and applies the latest data management standards and techniques to increase quality and efficiency

¨ Exhibits flexibility to adjust plans in response to unexpected events and outcomes to achieve team goals

¨ Adjusts well to changes in clinical, statistical programming, reporting and analysis processes affecting data management

¨ Proactively proposes data management process improvements to increase standardization and efficiency.

¨ Identifies specialty area difficulties and proposes solutions

¨ Actively participates in local data management or clinical development initiatives. Results Orientation

¨ Defines and manages detailed data management plans and deliverables in support of team goals

¨ Effectively manages external data management vendors

¨ Defines requirements, guides and monitors data management progress and resources provided by CROs.

¨ Anticipates and communicates to the study team and the manager, resource and quality issues that may impact deliverables. Proposes and implements solutions. Leadership

¨ Mentors other data analysts

¨ Actively shares expertise and learnings with other members of data management group and Biometrics organization.

¨ Helps to identify and utilize resources to increase data management and clinical trial expertise and performance

¨ Participates in external professional activities and organizations, such as CDISC, SCDM, DIA, etc.

 

Scope:

A Manager of Data Management provides assignments, coaching and high-level technical oversight.

Work is completed with minimal review

May direct data management project activities performed by other data analysts.

 

 Education and ExperienceRequired:

B.A. or B.S. (prefer medical/life science degree) with a minimum of 4 years experience supporting clinical trials

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

¨ Ability to drive to or fly to various meetings/sites – may include overnight stays and international travel

¨ Manual dexterity to operate office equipment (i.e. computers, phones, etc.)

¨ Ability to sit for long periods of time

¨ Ability to work with computer monitors for long periods of time

¨ Carrying, handling, and reaching for objects

 

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Due to travel, the work environment includes exposure to both inside and outside working conditions.  Temperature and length of exposure varies depending upon meeting location and transportation.