Global Data Manager

Description

Global Data Manager

POSITION TITLE:   Global Data Manager

POSITION SUMMARY:

·          Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations

·          Is the liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s)

·          Ensures Inspection Readiness of all data management deliverables and ensures adequate archiving of data management documentation

·          Is a member of SMT and Clinical Working Group(s) and leads the trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock)

·          Participates in or leads a non-trial related project within IDS or cross functionally

Position Scope:

GDM

·          Independently provide oversight and accountability for one low to moderate complexity trial

·          May be a member of one project of low to moderate complexity (='incremental innovations', operational improvements, low risk, restricted cross-functional involvement)

Senior GDM

·          Independently provide oversight and accountability for more than one low to moderate complex trial, or 1 high complexity trial

·          May be a member/leader of more than one project of low to moderate complexity, or member of one project of high complexity (='radical innovations', moderate to high risk, extensive cross-functional involvement)

GDM Specialist

·          Independently provide oversight and accountability for multiple low, moderate, high complexity trials

·          May be a member of multiple projects of low, moderate, high complexity, or leader of a project of high complexity

·          The GDM Specialist mentors and coaches GDMs and Senior GDMs on trial level responsibilities  

Principal GDM

·          Independently provide oversight and accountability for multiple moderate, high complexity trials

·          Assist the DML with cross-trial or program level oversight responsibilities

·          May be a member of multiple projects of moderate, high complexity, or leader of a project of high complexity

·          Collaborates with the DML and the DMTA Head to distribute work assignments and identify needed resources

·          Takes a leadership role to obtain, share, and develop best practices with internal and external partners

·          M entors and coaches GDMs, Senior GDMs, and Specialists on compound level responsibilities and may delegate work to GDM s, Senior GDMs, and Specialists

·           

PRINCIPAL RESPONSIBILITIES:

·          Liaises continually between the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s)

·          With the trial customer, CRO and other functional partners:

o     Gathers content and integration requirements for eCRF and other data collection tools

o     Establishes conventions and quality expectations for clinical data

o     Establishes expectations for dataset content and structure

o     Sets timeline and follow-up regularly to ensure delivery of all Data Management milestones

·          Performs trial level oversight controls as described in the oversight plan, QC process and work instructions

·          Prepares or reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensures compliance with regulatory guidelines and the documentation matrix

·          Ensures real-time inspection readiness of all IDS deliverables for the trial; Participates in Regulatory Agency and J&J internal audits as necessary

·          Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival;   ensures deliverables are on time and within budget

·          Supports the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met

·          Provides input to the DML on trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate

·          Identifies and communicates lessons learned, best practices and frequently asked questions at trial level

·          Identifies and participates in process, system, and tool improvement initiatives within IDS

·          Presents and trains at investigator and monitor meetings

• Participates in or leads non-trial/non-program projects based on specific expertise

RESPONSIBILITY FOR OTHERS (If applicable):

ADDITIONAL RESPONSIBILITIES:

• Collaborates with Vendor/CRO to achieve successful, cooperative partnerships; recognizes opportunities and contribute to solutions to strengthen the relationship
• Participates in internal/external staff mentoring and training

·          Reports directly to the functional manager and dotted line to the DML for a specific trial / to the DM Project Head or team leader for a specific project

·          Effectively Interacts with Global Trial Managers, Site Managers, Local Trial Managers, Trial Physicians, Safety Officers, DML, Clinical Team Leaders, Biostatisticians, Statistical Programmers, Medical Writers, Quality Monitoring personnel, Regulatory personnel, Standards/Library partners , R&D Partners, and   Governance Team

·          Facilitates effective information exchange/communication among clinical data management document authors/reviewers as appropriate (including problem-solving and resolution of issues) to ensure project success and collaborative support

·          Acts as the primary point of contact for the CRO on a specific trial

·          Effectively interacts with IT & External Service Providers

EDUCATION AND EXPERIENCE REQUIREMENTS:

Education:

·          BS/BA or equivalent work experience. Life sciences background a plus.

Experience:

·          At least 3 years of experience in Clinical Drug Development within the Pharmaceutical Industry or related Industry with proven track record; Data Management experience required.

Knowledge & Skills

• Thorough knowledge of the protocol
• Understanding of current clinical drug development processes
• Knowledge of applicable international guidelines regarding Data Management of clinical trials
• Relevant System / technical knowledge
• Knowledge and understanding of current industry standards (i.e. CDISC , SDTM , CDASH , etc.)
• Knowledge of technology platforms for data exchange

• Outstanding written and oral communication skills
• Negotiation skills

• Key Project Management Skills
• E ffectively prioritizing and managing multiple tasks simultaneously

• Excellent interpersonal skills
• Excellent problem solving and decision making skills
• Subject matter expertise available for internal staff/external partners