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Program Data Manager (Clinical Data Sciences). Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Program Data Manager (Clinical Data Sciences)

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Job ID:

23081

Location:

Cambridge, MA 

Job function:

Information Systems Management
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Program Data Manager (Clinical Data Sciences)

Job Description:

The Data and Analytics Lead manages the clinical data flow (data acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR)) and ensures timely project execution, recognized as an operational specialist in data flow and study execution by all functions across Development Sciences. Partners with key study team members to facilitate implementation of a robust and clear data strategy for assigned studies. Uses phase, TA and operational knowledge to establish study level operational plans and oversees CROs and other vendors to ensure timely execution. Develops study level quality plans and ensures adherence and consistent execution across the data flow. Collaborates with Program DALs to ensure alignment of study operational plans with program goals and for execution and quality.


  • Develops timeline and project manages data deliverables in collaboration with cross functional team members and vendors.
  • Oversees execution of data management deliverables. Interprets and applies data strategy, verifies consistency and usage of data, and results, Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data.
  • Develops risk mitigation or action plans and oversees execution when appropriate.
  • Serves as a contact representing DM within CDS and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (CDS functions, GCO, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
  • Serves as Subject Matter Expert alongside CDS counterparts for data, reporting, and analysis process definition, improvement, and innovation as needed.
  • Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed.
  • Support study-level audit and inspection readiness activities as needed.
  • Serve as project manager on special projects and initiatives, partners with Statistical Programming, VM and Quality depending on type of project.


    *LI-RD1
  • Job Requirements:

    Qualifications
  • 8+ years relevant work experience with a focus on data management
  • Deep understanding of drug development and biopharmaceutical industry required
  • Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
  • High attention to detail including proven ability to manage multiple, competing priorities
  • Experience overseeing outsourced clinical trials work
  • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
  • Deep knowledge of clinical data management outsourcing with full-service, global CROs and FSPs
  • Demonstrated ability to influence without authority
  • Excellent written and oral communication skills
  • Education
  • Bachelor's degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc
  • About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

    Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

    With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

    Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

    Zip Code:

    02142

    Company Info
    Biogen

    Cambridge, MA, United States

    Phone: +1 781-464-3260, +1 781-464-3260
    Web Site: www.biogene.com

    Company Profile

    Company Info


    Biogen
    Cambridge, MA, United States
    Phone: +1 781-464-3260, +1 781-464-3260
    Web Site: www.biogene.com

    Program Data Manager (Clinical Data Sciences)

    col-narrow-left   

    Job ID:

    23081

    Location:

    Cambridge, MA 

    Job function:

    Information Systems Management
    col-narrow-right   

    Posted:

    03.11.2016

    Employment Type:

    Full time

    Industry:

    Healthcare / Pharma
    col-wide   

    Title:

    Program Data Manager (Clinical Data Sciences)

    Job Description:

    The Data and Analytics Lead manages the clinical data flow (data acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR)) and ensures timely project execution, recognized as an operational specialist in data flow and study execution by all functions across Development Sciences. Partners with key study team members to facilitate implementation of a robust and clear data strategy for assigned studies. Uses phase, TA and operational knowledge to establish study level operational plans and oversees CROs and other vendors to ensure timely execution. Develops study level quality plans and ensures adherence and consistent execution across the data flow. Collaborates with Program DALs to ensure alignment of study operational plans with program goals and for execution and quality.


  • Develops timeline and project manages data deliverables in collaboration with cross functional team members and vendors.
  • Oversees execution of data management deliverables. Interprets and applies data strategy, verifies consistency and usage of data, and results, Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data.
  • Develops risk mitigation or action plans and oversees execution when appropriate.
  • Serves as a contact representing DM within CDS and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (CDS functions, GCO, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
  • Serves as Subject Matter Expert alongside CDS counterparts for data, reporting, and analysis process definition, improvement, and innovation as needed.
  • Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed.
  • Support study-level audit and inspection readiness activities as needed.
  • Serve as project manager on special projects and initiatives, partners with Statistical Programming, VM and Quality depending on type of project.


    *LI-RD1
  • Job Requirements:

    Qualifications
  • 8+ years relevant work experience with a focus on data management
  • Deep understanding of drug development and biopharmaceutical industry required
  • Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
  • High attention to detail including proven ability to manage multiple, competing priorities
  • Experience overseeing outsourced clinical trials work
  • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
  • Deep knowledge of clinical data management outsourcing with full-service, global CROs and FSPs
  • Demonstrated ability to influence without authority
  • Excellent written and oral communication skills
  • Education
  • Bachelor's degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc
  • About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

    Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

    With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

    Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

    Zip Code:

    02142
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