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Scientific. Clinical. Software Engineering

Senior Clinical Data Manager

New Jersey All, NJ

Job Type: Clinical Job Number: JN -012020-26231 Region: New Jersey All

Job Description

Responsible for the direct management and oversight of data management activities for assigned studies

Work in conjunction with the study team to ensure data review, project support, study document management and oversight of DM timelines, EDC/IWRS setup, study database design, clinical data capture, discrepancy management and data reconciliation

Primary point of contact between Data Management and the clinical team with respect to the management and oversight of data management activities

Author, review/revise Data Management related study plans including Data Management Plan, Data Validation Plan, Data Review Plan, CRF Completion Guidelines and other study documents to ensure quality and standardization

Collect approvals and provide authorization on DM deliverables including but not limited to finalized DM documents, database release to production and database lock

Work with vendor(s) particularly to support the DM tasks such as transfer of data

Manage design and development of eCRFs, including database UAT

Review CRF annotations, data mapping/data conversion plan, review of SDTM datasets, etc.

Oversee and manage the development and implementation of edit check specifications and work with database programmers during programming and validation

Manage and oversee data management related activities for the ongoing study

Lead DM study meetings; distribute agenda, create minutes capturing action items and decisions

Lead data reviews with clinical team to ensure accuracy, consistency and reliability of data

Review database metrics and follow escalation process to achieve resolution of noted issues

Collaborate with study team to ensure study databases are locked based on pre-defined criteria and timelines

Ensure that CDM procedures and processes meet business requirements and are adhered to in a consistent manner

Provide high quality services through efficient and compliant processes

May mentor/oversee DM staff assigned to study for which they are designated as DM Study Lead

Requirements:

Bachelor s Degree in scientific or technical discipline

Minimum five years of clinical data management experience in a biotech, pharmaceutical or CRO environment (or equivalent)

Experience with all aspects of DM including Database Build, Study Startup, Study Conduct and Database Closure activities

Hands on experience with Electronic Data Capture systems required (Medidata Rave) and ad hoc query tools required (JReview, other desired)

Experience in CRO and vendor management required

Experience with multiple trial phases of clinical development

Must have excellent communication skills (verbal and written)

Highly organized with a strong attention to detail, clarity, accuracy and conciseness

Strong collaboration skills regarding external and internal teams, and working in a cross- functional team environment

Demonstrated ability to prioritize work

Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Knowledge & experience:

Expert level proficiency in DM systems, processes and procedures

Authored DM documents (Data Management Plan, Data Validation Specifications/ Plan, Data Review Plan, CRF Completion Guidelines, Data Transfer Agreements, etc.)

Designed CRFs against study protocol

Performed database UAT testing and prepared documentation

Conducted data reviews

Experienced with coding and data standards

Audited, filed DM documents in designated study repository (highly desirable)

Locked databases

Must successfully exhibit core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies

Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

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