Requisition ID 16131BR
Title Senior Clinical Data Analyst
Job Category Clinical
Job Description PURPOSE:
Responsible for the support of assigned trials in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR, as well as DM staff members in NN global DM community.
RELATIONSHIPS:
Reports to Associate Manager / Manager / Senior Manager of Data Management (DM) within CTM. Accountable for actively participating in multiple cross-functional teams locally and/or globally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.
ESSENTIAL FUNCTIONS:
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
FUNCTIONAL SUPPORT:
- May participate in continuous improvement processes for function as Subject Matter Experts (SME).
PROJECT SUPPORT:
- Accountable for the quality and maintenance of clinical Data Management System (OC, EDC) in accordance with NNI SOPs. Performs ongoing data cleaning and reviews to assure quality of the data and compliance with NNI SOPs, GCP and ICH Guidelines.
- Accountable to provide data management documentations to support study activities.
- Act as primary DM for assigned studies to convey project information, answer questions and report to study group (including ISG meetings) during trial conduct and closure phases.
- Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of DM documentation.
- Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
- Collaborates with RTM / LTM / PM to obtain/share trial specifics issues across all study sites concentrating on areas related to data quality, site performance and metrics. Responsible for communicating issues in accordance with the project or CTM escalation pathway
- Create, review and utilize study related tracking systems to determine and report status of clinical trial data and responsible for the follow up to collect outstanding documents and resolve issues.
- Ensure DM documents are maintained during the lifecycle of assigned project in collaboration with project team locally and globally.
- Maintain trial Data Flow Plan and responsible for carrying out DM tasks according to data flow plan for assigned trials.
- Provides quality overview and consistency check on all clinical data and DM trial documents (DHP, TDR, etc.)
- Responsible to assure adequate and appropriate dissemination of information according to the study specific communication plan between DMs, in house and regionally based staff locally and globally to ensure project success.
- Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met for all data collected.
STAFF DEVELOPMENT:
- Provide active mentorship to Clinical Data Analyst and CTM staff to build talent across the department.
TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams, contributor to Clinical Team Unit (CTU) Meetings.
- Participates in cross-functional teams, locally and globally, to assure timely attainment of project milestones.
- Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible to ensure that the mandatory DM trial documents are filed in NovoDOCs,
- Responsible to maintains focus, locally, for specific project activities within CMR priorities.
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support of training needs across CTM and may support the creation, development and provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM
PHYSICAL REQUIREMENTS:
- Office Based in Princeton, NJ.
DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department.
- May support the maintenance of guidelines, training programs, policies and procedures.
- Support in the identification of training gaps and the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree (in science area) or registered nurse, (4 year degree). Advanced degree preferred.
- At least a Minimum of 6 years of clinical trial experience within pharmaceutical and/or healthcare setting, direct expertise of data management in clinical trials for at least 3 years.
- Demonstrated basic programming knowledge of SAS, and SQL
- Demonstrated computer skills in Oracle Clinical, Clintrial, EDC, MS Office, MS Project, PowerPoint including DB knowledge
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
Department CMR - CLINICAL DATA MANAGEMENT (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Title Senior Clinical Data Analyst
Job Category Clinical
Job Description PURPOSE:
Responsible for the support of assigned trials in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR, as well as DM staff members in NN global DM community.
RELATIONSHIPS:
Reports to Associate Manager / Manager / Senior Manager of Data Management (DM) within CTM. Accountable for actively participating in multiple cross-functional teams locally and/or globally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.
ESSENTIAL FUNCTIONS:
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
FUNCTIONAL SUPPORT:
- May participate in continuous improvement processes for function as Subject Matter Experts (SME).
PROJECT SUPPORT:
- Accountable for the quality and maintenance of clinical Data Management System (OC, EDC) in accordance with NNI SOPs. Performs ongoing data cleaning and reviews to assure quality of the data and compliance with NNI SOPs, GCP and ICH Guidelines.
- Accountable to provide data management documentations to support study activities.
- Act as primary DM for assigned studies to convey project information, answer questions and report to study group (including ISG meetings) during trial conduct and closure phases.
- Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of DM documentation.
- Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
- Collaborates with RTM / LTM / PM to obtain/share trial specifics issues across all study sites concentrating on areas related to data quality, site performance and metrics. Responsible for communicating issues in accordance with the project or CTM escalation pathway
- Create, review and utilize study related tracking systems to determine and report status of clinical trial data and responsible for the follow up to collect outstanding documents and resolve issues.
- Ensure DM documents are maintained during the lifecycle of assigned project in collaboration with project team locally and globally.
- Maintain trial Data Flow Plan and responsible for carrying out DM tasks according to data flow plan for assigned trials.
- Provides quality overview and consistency check on all clinical data and DM trial documents (DHP, TDR, etc.)
- Responsible to assure adequate and appropriate dissemination of information according to the study specific communication plan between DMs, in house and regionally based staff locally and globally to ensure project success.
- Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met for all data collected.
STAFF DEVELOPMENT:
- Provide active mentorship to Clinical Data Analyst and CTM staff to build talent across the department.
TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams, contributor to Clinical Team Unit (CTU) Meetings.
- Participates in cross-functional teams, locally and globally, to assure timely attainment of project milestones.
- Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible to ensure that the mandatory DM trial documents are filed in NovoDOCs,
- Responsible to maintains focus, locally, for specific project activities within CMR priorities.
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support of training needs across CTM and may support the creation, development and provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM
PHYSICAL REQUIREMENTS:
- Office Based in Princeton, NJ.
DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department.
- May support the maintenance of guidelines, training programs, policies and procedures.
- Support in the identification of training gaps and the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree (in science area) or registered nurse, (4 year degree). Advanced degree preferred.
- At least a Minimum of 6 years of clinical trial experience within pharmaceutical and/or healthcare setting, direct expertise of data management in clinical trials for at least 3 years.
- Demonstrated basic programming knowledge of SAS, and SQL
- Demonstrated computer skills in Oracle Clinical, Clintrial, EDC, MS Office, MS Project, PowerPoint including DB knowledge
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
Department CMR - CLINICAL DATA MANAGEMENT (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%