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Miles
Km80.5

Director, Clinical Data Manager

Synarc, Inc.

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Location: Newark, CA Posted Date: 4/22/2013 Position Type: Full time Job Code: 10000 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management

Description

Essential/Primary Duties, Functions And Responsibilities
·        Provides leadership to the Clinical Data Management function and serves as a member of the Leadership Team.
·        Recruits, retains, trains and manages employees and consultants with area of responsibility
·        Partners with supervisor to contribute to technical infrastructure of the clinical programming computing environment; and process improvement
·        Identifies, develops, and implements strategy for the improvement of productivity and standardizing of Clinical Data Management and Clinical Data Programming activities
·        Provides technical expertise to clinical data management and clinical data programming project to improve operational effectiveness
·        Oversees all data management and clinical programming support activities for a clinical program for timely and accurate data acquisition, integration, analysis and interpretation of results. Assure team is adhering to guidelines, budgets and timelines of projects
·      Oversees all programming support activities for a clinical program in line with timely and accurate data acquisition and integration before data base is ready for analysis and interpretation of results
·        Responsible for execution of ad hoc requests, and other reports as required
·        Provides leadership in facilitating knowledge sharing and creation, leading to best practice and improved quality and processes in Data Management and Clinical Programming
·        Implementation of documentation and archival standards of Data Management and Clinical Programming deliverables including DM systems, databases, programs, and specifications.
·          Establishes and negotiates timelines with internal and external team members for completion of activities for a group of projects
·        Oversees project management for Data Management and Clinical Programming deliverables across functional area
·          Develops, applies and promotes consistent programming standards through standard processes and SOPs
·        Identifies areas of deficiency requiring SOPs or guidelines and execute a plan to rectify
·        Ensures that guidelines and specifications on validation procedures and data transfer procedures are followed and appropriate documentation surrounding maintaining, archiving clinical data and/or programs are maintained
·          Represents function in external professional initiates and organization to identify industry best practices
·          Other duties as required

Work Experience:

·  Bachelor in Computer Sciences, Mathematics, Life Sciences with 5+ years’ data management and clinical programming experience in the pharmaceutical or biotechnology industry, or MA/MS with 5+ years’ of experience
·  10+ years of regulatory experience
·  ·  Expert at clinical data management in a pharmaceutical or CRO working in a FDA regulated environment
·  Expertise in Electronic Data Capture (EDC) technologies and data management a must.
·  Proven track record in forming and managing a functional team to support multiple projects
·  Experience in the management projects; Experience in working in and contributing to cross-functional teamsManagement of Staff: Manages group of internal clinical data managers and clinical programmers, consultant data managers and clinical programmers. Mentors and develops direct employees


PLEASE APPLY AT https://home.eease.adp.com/recruit/?id=4802321

Requirements

Functional/Technical Knowledge & Skills:
·        Excellent critical thinking, strategic and analytical skills are required with a team approach to problem solving
·        Good working knowledge of ICH, FDA, and GCP regulations and guidelines; Strong well-rounded technical skill, SAS, SDTM and CDISC
·         Demonstrated success in leadership roles contributing to critical regulatory submissions such as safety updates, FDA requests, and/or briefing documentsCustomer & Industry Knowledge:

·  Has scientific background and understanding of clinical trials, pharmaceutical operations, and regulatory compliance
·  Supporting DMC and IRC; working directly with DMC and/or IRC; working with steering committees

Education/Training:
·  Bachelor in Computer Sciences, Mathematics, Life Sciences with a minimum of 5 years of data management and clinical programming experience in the pharmaceutical or biotechnology industry, or MA/MS with a 5+ years’ of experienceOther Requirements: Sufficient verbal/written and interpersonal skills required for working successfully in a cross-functional team environment; Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email and may require travel up to 15% of time.

 

 

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