Advance Your Life Sciences Career

Manage all aspects of the clinical data management process from study start-up to database lock for in-house Electronic Data Capture (EDC) trials including data management performance, metrics, quality assurance checks and communication of trial status within and outside the trial team.

• Manage / assign responsibilities for Data Managers and also serve as a member of Study Teams. Act as primary Data Management contact and contributor for projects
• Create / monitor timelines and ensures that all deadlines are met with quality
• Participate in the review of clinical data, analysis tables, listings, figures, and patient profiles for data consistency and accuracy
• Identify and troubleshoot operational problems and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
• Develop and support creation of data management documentation, specifications and UAT requirements for database and test according to UAT Plan
• Create, review and revise data management documentation
• Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs, and meet all regulatory requirements
• Requirements:
• Identify project challenges and risks, and proposing appropriate and strategic solutions to issues
• Electronic data capture experience (Medidata Rave®) and working knowledge of Oncology indications
• Proficient in data management activities including CRF and clinical database design, clinical data cleaning and analysis for Oncology trials

Responsible for operational aspects of planning and management of site performance in accordance with departmental expectations. May act as primary liaison between in-house CRAs, field based CRAs and the Clinical Project Manager (CPM). Supports and assists Clinical Project Managers in operationalizing multiple clinical research studies.

• Supports preparation and may develop materials related to the training and presentations for Investigator Meetings.
• Facilitates CRA project meetings.
• Assist in the oversight of monitoring staff including the tracking and review of monitoring trip reports and escalate any trends with respect to data quality or study conduct to the appropriate CPM.
• Track and report on progress of the study including site activation, patient enrollment and monitoring visits.
• Ensures that all sites are provided supplies in accordance with study start-up expectations.
• Identify potential risks to the enrollment targets based on feasibility analysis in collaboration with the CPM.
• Develop PSV/SIV/IMV and other training tools and training materials in support of the project.
• Assist in the review of CRO and other third party vendors invoices to ensure that work is performed in accordance with scope of work.
• Ensure that monitoring visits are performed in accordance with the protocol, monitoring plan, and applicable SOPs.
• Responsible for the development of any mass site communication as appropriate.
• Responsible for operationalizing clinical protocols at the site level and ensuring appropriate SOPs are being followed for each process, depending on the study.
• Participate in eCRF in User Acceptance Testing (UAT) and the creation of eCRF completion guidelines and ensuring site level access to eCRFs throughout the conduct of a study.
• Work with CRAs in proactively maintaining / up-dating essential documents as required, to ensure compliance with protocol and regulations.
• Contact sites as needed for data entry/data quality concerns and alert CRA of any issues prior to the next scheduled monitoring visit.
• Assist with study start-up activities including development of the first draft of the ICF.
• Assist with the review of protocol, protocol amendments, ICF and CSR documents as required.
• Provide active mentorship of CTA staff to build talent across the department.
• Agenda distribution & minute taking for internal study team meetings.

• Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required.
• Experience working in clinical research within a pharmaceutical company or CRO or similar organization.
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
• Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
• Ability to work successfully within a cross-functional team.
• Strong knowledge of applicable computer and project management software packages.
• Excellent written and oral communication skills.
• Ability to interact with investigators, vendors, and internal colleagues.
• Knowledge of current regulatory requirements and guidelines governing clinical research.
• Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner.

RESPONSIBILITES:

• Lead Data Management function and help grow DM services. This includes a mix of both individual hands-on DM activities, as well as people and process management.
• Serve as a “face to the client” for at-large relationship management to external clients.
• Coordinate resource allocation on designated projects for the Vita Data Sciences team.
• Participate as a thought leader in the space to the at-large life sciences community.
• In coordination with the management of Vita Data Sciences, contribute to the strategic direction and growth of the organization.
• Interface with the VDS Business Development and Recruiting teams to ensure that resource allocation and scopes or work are properly aligned.
• Build and lead a team of additional data managers and EDC developers to support multiple clients.
• Knowledge of CDISC CDASH and SDTM standards implementation and guidance.
• Effectively implement and promote use of established standards, SOP and best practices.

MINIMUM REQUIREMENTS:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification with 10+ years of DM experience.
• 3+ years of leadership and/or mentoring experience in a clinical study environment.
• 7+ years of experience with DM activities including EDC set-up, data cleaning, data reconciliation, data review and database lock.
• Experience working in multiple therapeutic areas.
• Good organizational, interpersonal, leadership and communication skills.
• Provide training and mentoring to the team.

Responsibilities

• Develop statistical programs in SAS to generate the clinical datasets, tables, listings and figures.
• Perform validation and QC of the programs, datasets and statistical reports per study requirements.
• Develop and review CDISC SDTM and ADaM mapping specifications.
• Responsible for study closeout and providing submission-ready statistical programming deliverables to the client.
• Ensure compliance of CDISC SDTM and ADaM datasets by running OpenCDISC validator and documenting issues.
• Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide.
• Ensure review of study documents such as Protocol, CRF, and SAP.
• Communicates effectively within a project team to complete assigned tasks on time and within budget.
• Effectively implement and promote use of established standards, SOP and best practices.
• Provide training and mentoring to junior programmers in the team.

Requirements

• Master’s degree or equivalent and relevant formal academic / vocational qualification.
• 3yrs SAS programming experience.
• 1yr CDISC implementation experience.
• Proficient in SAS and Macros and have developed macros to automate functionality.
• Experience working in Oncology therapeutic area
• Participated as production or QC programmer at a product and/or study level.
• Good organizational, interpersonal, leadership and communication skills.
• Ability to independently manage multiple tasks and projects.

Responsibilities:

• Develop statistical programs in SAS to generate the clinical datasets, tables, listings and figures.
• Perform validation and QC of the programs, datasets and statistical reports per study requirements.
• Develop and review CDISC SDTM and ADaM mapping specifications.
• Responsible for study closeout and providing submission-ready statistical programming deliverables to the client.
• Ensure compliance of CDISC SDTM and ADaM datasets by running OpenCDISC validator and documenting issues.
• Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide.
• Ensure review of study documents such as Protocol, CRF, and SAP.
• Communicates effectively within a project team to complete assigned tasks on time and within budget.
• Effectively implement and promote use of established standards, SOP and best practices.
• Provide training and mentoring to junior programmers in the team.

Requirements:

• Master’s degree or equivalent and relevant formal academic / vocational qualification.
• 5yrs SAS programming experience.
• 1-2yrs CDISC implementation experience.
• Proficient in SAS and Macros and have developed macros to automate functionality.
• Participated as production or QC programmer at a product and/or study level.
• Experience working in Oncology, CNS or Rare Disease therapeutic areas.
• Good organizational, interpersonal, leadership and communication skills.
• Ability to independently manage multiple tasks and projects.

The Senior Biostatistician is responsible for providing statistical support as assigned by the Manager. He/She participates in the development of study protocols including participation in study design discussions. He/She also reviews CRFs and data edits and may serve as primary biostatistician on one or more projects.

This person develops statistical analysis plans including analysis file and report specifications. He/She performs statistical analyses, interprets statistical results, and prepares clinical study reports including integrated summaries for submissions

• Participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
• Performing statistical analyses
• Preparing clinical study reports, including integrated summaries for submissions;
• Master’s degree in statistics or a related discipline. PhD strongly desired.
• 5-10 years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
• Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
• Knowledge and implementation of advanced statistical methods.
• Strong knowledge of ICH guidelines.
• Interpreting statistical results
• Solid understanding & implementation of CDISC requirement for regulatory submissions.