Job Overview:  

The Clinical Data Manager III is responsible to participate the clinical data management activities for a project within a data management team; including processing of Case Report form and electronic data, processing and reconciliation of external data, SAE reconciliation and supporting the database close/lock procedures in accordance with Caidya SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.  Work as a Project Point of Contact (POC), manage work allocation and work with minimal or no supervision.

 Job Duties and Responsibilities:

The specific job duties of a Clinical Data Manager III may include but are not limited to:

• For specified projects performs start-up activities including:
  • Developing data management guidelines and study documentation
  • Review of CRF design against protocol
  • Lead study developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation. Activities include design, database structure, document creation; including approval
• For specified projects performs data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
  • Study status tracking
  • Review of data listings
  • Identification of data issues and query generation
  • Updating of database with query resolutions (paper studies only)
  • Processing and reconciliation of external data including SAE reconciliation
  • Ownership and proactive management of the data reconciliation activities documented in the DVP, DMP, etc.
  • Provide input for Database closeout and lock activities and timelines
  • Archiving of critical documents on an ongoing basis
  • If assigned the Lead Data Manager role, act as key data management contact for the project.
• Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
• Proactively manage project quality through supervision and quality control of team members’ work.
• Proactive participation in appropriate sponsor/project team meetings.
• Active involvement in departmental and organizational meetings and initiatives.
• Develops and documents departmental procedures.
• Training and Mentoring of team members in accordance with established departmental procedures.
•  Supports and tracks budget adherence in cooperation with Finance to ensure the assigned studies are meeting targeted margins and utilization.
• Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology and incorporating innovation to optimize delivery.
• Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure Caidya DM procedures are in line with industry expectations.
• Indirect supervision of the work of junior members of the project team.
• Other duties as assigned.

 Supervisory Responsibilities:

No supervisory responsibilities.

 Job Requirements:

• Education
  • College graduate with a degree in life science, computing or nursing qualifications preferred; or 3 to 4 years equivalent experience.
• Experience
  • Minimum of 5 years of experience and/or demonstrated aptitude for data management work.  International team experience preferred.
  • Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
  • Prior trial responsibility for entire data management life-cycle
  • Working knowledge of EDC studies
• Skills/Competencies
  • Excellent organizational skills
  • Strong written and verbal communication skills
  • Exceptional attention to detail
  • Knowledge of clinical research including regulatory requirements GCP/ICH
  • Strong interpersonal skills; serve as the point of contact for data management activities
  • Strong computer skills, including Microsoft Office and clinical data management systems
  • Demonstrated problem-solving skills
• Capabilities
  • Flexibility - willing to change assignments and work focus to accommodate project demands
  • Team player – effective proactive participant as a team member.

Location:  IND-Home-Based, India
Job ID: 23006828

Description

With over 7 years of experience and more than 200 employees in over 4 countries, Sigma-Chi is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Leipzig, Germany, and we have affiliates in 3 European countries and USA.

JOB SUMMARY

This position functions as a member of the Biostatistics and Statistical Programming project team serving as a lead statistical programmer or reviewer for any project, especially those of high complexity and scope, or integrated summaries of safety/efficacy for submission, in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project or across a program or submission; manages project budgets and tracks project specific performance metrics; functions as an internal and external customer liaison; provides input to statistical analysis plans; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages. A Principal Statistical programmer demonstrating a high degree of expertise of CDSIC and other industry standards / tool and regulatory requirements may serves as a subject matter experts leading innovations and providing guidance to the Biostatistics Department.

JOB RESPONSIBILITIES

• Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. 
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Conducts effective internal meetings (appropriate in format, frequency and attendance).  Distributes relevant information in advance.  Ensures minutes are promptly and accurately distributed.  Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.
• Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design.  Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.
• Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. 
• Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
• When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.
• Transfers deliverables.
• Performs other work-related duties as assigned.
• Minimal travel may be required

Qualifications

What we’re looking for
•    Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and 8+ years of experience in Clinical SAS programming.

• Extensive programming experience in SAS, ADAM, TLF, SDTM or other required software in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.
• Experience in submissions to a regulatory agency is required
• Experience in mentoring others in clinical trial process and CDISC Standards.
• Excellent written and verbal communication skills.

Ability to read, write, speak and understand English.

Job Overview:  

The Clinical Data Manager III is responsible to participate the clinical data management activities for a project within a data management team; including processing of Case Report form and electronic data, processing and reconciliation of external data, SAE reconciliation and supporting the database close/lock procedures in accordance with Caidya SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.  Work as a Project Point of Contact (POC), manage work allocation and work with minimal or no supervision.

 Job Duties and Responsibilities:

The specific job duties of a Clinical Data Manager III may include but are not limited to:

• For specified projects performs start-up activities including:
  • Developing data management guidelines and study documentation
  • Review of CRF design against protocol
  • Lead study developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation. Activities include design, database structure, document creation; including approval
• For specified projects performs data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
  • Study status tracking
  • Review of data listings
  • Identification of data issues and query generation
  • Updating of database with query resolutions (paper studies only)
  • Processing and reconciliation of external data including SAE reconciliation
  • Ownership and proactive management of the data reconciliation activities documented in the DVP, DMP, etc.
  • Provide input for Database closeout and lock activities and timelines
  • Archiving of critical documents on an ongoing basis
  • If assigned the Lead Data Manager role, act as key data management contact for the project.
• Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
• Proactively manage project quality through supervision and quality control of team members’ work.
• Proactive participation in appropriate sponsor/project team meetings.
• Active involvement in departmental and organizational meetings and initiatives.
• Develops and documents departmental procedures.
• Training and Mentoring of team members in accordance with established departmental procedures.
•  Supports and tracks budget adherence in cooperation with Finance to ensure the assigned studies are meeting targeted margins and utilization.
• Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology and incorporating innovation to optimize delivery.
• Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure Caidya DM procedures are in line with industry expectations.
• Indirect supervision of the work of junior members of the project team.
• Other duties as assigned.

 Supervisory Responsibilities:

No supervisory responsibilities.

 Job Requirements:

• Education
  • College graduate with a degree in life science, computing or nursing qualifications preferred; or 3 to 4 years equivalent experience.
• Experience
  • Minimum of 5 years of experience and/or demonstrated aptitude for data management work.  International team experience preferred.
  • Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
  • Prior trial responsibility for entire data management life-cycle
  • Working knowledge of EDC studies
• Skills/Competencies
  • Excellent organizational skills
  • Strong written and verbal communication skills
  • Exceptional attention to detail
  • Knowledge of clinical research including regulatory requirements GCP/ICH
  • Strong interpersonal skills; serve as the point of contact for data management activities
  • Strong computer skills, including Microsoft Office and clinical data management systems
  • Demonstrated problem-solving skills
• Capabilities
  • Flexibility - willing to change assignments and work focus to accommodate project demands
  • Team player – effective proactive participant as a team member.

Date: 8 Dec 2023

Location: Nationwide, Germany, 81379

Company: Sigma-Chi Europe

Passion for Innovation. Compassion for Patients.

With over 7 years of experience and more than 200 employees in over 4 countries, Sigma-Chi is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Leipzig, Germany, and we have affiliates in 3 European countries and USA.

We are looking for a:

Director Biostatistics (m/f/x)

The position holder is responsible for leading biostatistical strategy and accountable for all biostatistical activities for Medical Affairs, Health Economics and Outcome Research and Health Technology Assessment for at least one compound by contributing to evidence generation plan, pricing authorities' interactions and scientific communication.

The position holder will be responsible to coordinate other biostatisticians assigned to the same compound as well as interact and ensure alignment with data management and statistical pro-grammers.

The position will either be based in one of our offices in Europe or from home within one of these countries.

Roles and responsibilities:

Project Responsibility

• Accountable for all functional activities for at least one Compound
• Act as the functional expert within the assigned program, ensuring that activities for Evidence Generation are scientifically sound and that the evidence generated meets requirements of internal and external stakeholders
• Take responsibility as project lead for all deliverables performed by biostatisticians across the global / regional evidence generation activities
• May lead critical studies from design to analysis execution and interpretation and contribute to documents submitted to Regulatory or Pricing Authorities

Operational Excellence and Innovation

• Sponsor, lead and participate in initiatives to improve the harmonization and efficiency of processes and develop and implement innovative solutions
• Maintain current knowledge of industry best practice in statistical methodology
• May act as Subject Matter Expert for Biostatistics, by providing guidance and support to team members and cross-functionally
• Monitor regulatory guidance and industry best practices to formulate proposals for new functional standards

Line Management activities

• Lead a team including recruitment, coaching, mentoring, people development, talent & performance management
• May lead a cross functional project team

Vendor Oversight

• Responsible for providing senior governance, direction, and execution of oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, regulatory and other relevant guidelines
• Responsible for CRO selection

Personal skills and professional experience:

• Master’s degree or PhD (preferable) in statistics, mathematics or related fields
• At least 10 years of experience as statistician (with at least 3 in Pharma) supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting
• Experience in oncology Therapeutic Area or in late phase projects is an advantage
• Extended and up-to-date knowledge of statistical methods related to clinical studies and to HEOR/HTA applications
• Knowledge of CDISC standards and statistical software such as SAS and/or R
• Extended knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research
• Demonstrated expertise in study design, conduct and execution
• Excellent English language skills 
• Excellent communication skills, both oral and written, in explaining in simple terms complex concepts
• Good negotiation and project management skills 
• Demonstrated entrepreneurship and leadership and proactive problem solving
• Ability and interest to work remotely with

Why work with us?

Working at Sigma-Chi is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.sigma-chiconsulting.com