Sr Associate Clinical Master Data Management Job at Amgen (Hyderabad)

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Sr Associate Clinical Master Data Management

The Master Data Analyst at Amgen will support the accuracy and consistency of ma...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a STEM discipline and 5 years of experience in SAP ECC, clinical master data management, data governance, or data operations, preferably in the healthcare or biotech supply chains
Experience in SAP/Oracle, Microsoft Office (Excel, PowerPoint), and other data management tools (e.g., Informatica, Oracle MDM)
Strong ability to analyze large datasets and deliver actionable insights
Skilled at identifying root causes of data issues and implementing effective solutions
High accuracy and attention to detail, with a strong focus on data quality
Excellent written and verbal communication skills, with the ability to present findings to both technical and non-technical stakeholders
Working knowledge of SAP/Oracle
Understanding of master data management processes, frameworks, and governance
Proficiency in Excel and MS Office Suite, with experience in data analysis
Basic understanding of data governance frameworks and ensuring data accuracy and quality

Job Responsibility

Perform data operations tasks, mainly maintenance, and validation, to ensure the accuracy and integrity of master data
Follow Principles of Handling and Access to Restricted Data for Clinical master data
Initiation and maintenance of the study integrity document (SID) for Clinical master data
Support process optimization initiatives to improve data management workflows and enhance efficiency
Conduct data analysis to identify trends, discrepancies, and opportunities for improvement
Provide training and support to partners, customers, and end-users on master data processes, tools, and best practices
Maintain data quality reports to monitor performance metrics and ensure data compliance
Collaborate cross-functionally with business, IT, and operations teams to resolve data-related issues and ensure alignment with organizational goals

Fulltime

Sr. Data Associate, Data Management Science

The Senior Data Associate supports the Clinical Program and acts as the GDS DMS ...

Location

United States , San Rafael or Brisbane

Salary:

96000.00 - 144000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

MA degree preferred, or BA/BS degree with a focus in statistics, computer science, life science, or related scientific discipline
2+ years of experience in clinical development, including technical experience within and outside of Data Management, with MS
5+ years with BS
Decision Making, Critical thinking and Problem Solving
Influence, Cross-Functional Collaboration and Organizational Awareness
Agility and Proactivity
Leadership
Communication
Strategic Thinking and Planning
Operations

Job Responsibility

Draft Case Report Form (eCRF) in a concise, self-explanatory, and user-friendly format
Draft Data Management Plan outlining key Data Management activities and deliverables
Collaborate with Clinical Programming and Data Quality Science and facilitate the completion of the Data Validation Plan
Conduct appropriate ongoing/periodic data validation activities
Draft data transfer specifications
Conduct SAE reconciliation activities
Maintain data transfer calendar requirements
Post listings/reports/profiles to study file locations
Reconcile external data
Maintain and track timeline, discrepancies, query resolution, and deliverable status

What we offer

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Sr. Practice Manager

Sr. Practice Manager is responsible for the day-to-day management and strategic ...

Location

United States of America , Rochester

Salary:

28.50 - 37.06 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Associate's degree preferably with coursework in business administration or health care administration and 3 years administrative experience required and 2 years management experience in healthcare required
Electronic Medical Record (EMR) skills with expert proficiency in all aspects, including Master Scheduling and Billing knowledge
Advanced knowledge of medical practices, terminology, and reimbursement policies
Intermediate Microsoft Outlook email skills (open new, to, cc, send)
Intermediate electronic filing skills (name a file, save file, save as)
Advanced typing skills
Advanced proficiency with Microsoft Word and Excel
Travel to office sites

Job Responsibility

Responsible for the day-to-day management and strategic oversight of a high-volume Neurosurgery & Neuromedicine Pain ambulatory practice comprising 30+ exam rooms and procedural space
Accountable for driving operational efficiency, monitoring and improving key ambulatory performance metrics, ensuring high-quality care delivery, enhancing the patient experience, and supporting strong financial performance
Leads a diverse, professional team of non-clinical staff using the ICARE framework (Integrity, Compassion, Accountability, Respect, Excellence), fostering a culture of collaboration, inclusion, and continuous improvement
Oversees the clinical facility’s operations, ensuring compliance with all regulatory requirements, safety standards, and organizational policies
Manage operations for a 30+ Neurosurgical/multispecialty clinic
Ensures adherence to proper patient registration and insurance pre-verification processes
Responsible for the management of Neuromedicine Pain Program, including direct supervision of the Pain Management staff
Prepares and maintains weekly staffing schedules
Collaborates with providers to develop and maintain scheduling templates
Manage and monitor volume of patients in clinic and assign providers exam and dictation space

Fulltime

New

Sr Associate Clinical Supply Chain Support Office

In this vital role, you will serve as Sr Associate, supporting the Design and Se...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

5 Years of experience with Bachelor degree or equivalent in logistics, business administration or life science
Typically relevant working experience, preferably in the biotechnology or pharmaceutical industry
Typically relevant working experience in an international and regulated environment
Understanding of fundamentals of logistics/supply chain principles (especially BOM)
Experience in planning
Experience in project management techniques
Advanced experience in MS Office applications (Word, Excel)
Fluency in English, both in oral and written communication
High quality standards with regards to work
Ability to set priorities and timely escalation

Job Responsibility

Master Data in ERP (SAP)
Initiate clinical label material requests
Requesting Finished Drug Product Materials, Bill of Materials (BOM), Work Breakdown Structure (WBS) elements, Custom Values and ensures timely availability to adhere to overall project timelines
Ensures setup of Study Design Tables
Coordinate and prioritize artwork creation process via initiation and routing of clinical artwork creation request forms, facilitating discussions to resolve issues and following up on outstanding queries
Creates and maintains Product Specification File Study throughout the life cycle of the clinical trial
Creates and maintains third party depot plans and cross docks to support global study footprint
Maintains Metrics for Global Setup lead team
Contributes to monthly Workforce planning cycle

Fulltime

Associate director, biostatistics

The Associate Director, Oncology Biometrics is a skilled biostatistician who can...

Location

United States , Bothell; La Jolla; Cambridge; Groton; New York City

Salary:

139100.00 - 225100.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Ph.D. in Statistics, Biostatistics or a related field with 5+ years of experience, or a master’s degree in Statistics, Biostatistics or related field with 7+ years of experience in clinical trials
Demonstrated high aptitude in FDA/EMA and other regulations
Demonstrated high aptitude in ICH GCP guidelines
Demonstrated high aptitude in Drug development process
Demonstrated high aptitude in CDISC standards and implementation guides
Demonstrated high aptitude in Statistical methods and applications to clinical trial design and data analysis
Demonstrated high aptitude in Programming skills in R and/or SAS
Demonstrated high aptitude in Company SOPs and business practices
Demonstrated ability to develop and deliver multi-mode communications
Demonstrated ability to manage multiple projects

Job Responsibility

Serve as a study statistician for assigned clinical studies related to one or more clinical programs
Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner
Provide statistical inputs on clinical development plans
Contribute to the development of clinical study protocols and author the statistical sections
Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad-hoc analyses
Develop study randomization specification and verification documents as necessary
Perform sample size calculations and assess trial design operating characteristics under various assumptions
Review CRFs and edit checks and participate in UAT of different systems
Review dataset programming specifications, key derived variables, and statistical deliverables
Independently derive from source data key efficacy variables and analyses

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Sr. Practice Manager

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

28.50 - 37.06 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Associate's degree preferably with coursework in business administration or health care administration required
3 years administrative experience required
2 years management experience in healthcare or an equivalent combination of education and experience
Electronic Medical Record (EMR) skills with expert proficiency in all aspects, including Master Scheduling and Billing knowledge required
Advanced knowledge of medical practices, terminology, and reimbursement policies required
Intermediate Microsoft Outlook email skills (open new, to, cc, send) required
Intermediate electronic filing skills (name a file, save file, save as) required
Advanced typing skills required
Advanced proficiency with Microsoft Word and Excel required
Travel to office sites required

Job Responsibility

Oversees the operational components of the 7 procedure rooms in the Cardiac Catheterization and Electrophysiology Lab and the 17 exam rooms in the Paul Yu Heart Center
In conjunction with clinical leadership, promotes operational efficiency, high quality, outstanding patient experience, and strong financial performance
Directs staff using the ICARE framework, promoting a collaborative, diverse, and professional team
Responsible for performance management of all non-clinical staff in the practice
Operations Management: Supervises the operation and implement procedures for enhancing levels of service and quality and enforces medical office policies and procedures for the Cardiac Cath and EP Lab and the Paul Yu Heart Center
Develop guidelines for prioritizing and assigning work activities, evaluating effectiveness and modifying processes as necessary
Establishes and maintains efficient and responsive patient flow system
Ensure proper registration and insurance pre-verification management processes are followed including warm transfers to centralized functions
Manages insurance prior authorization for procedures scheduled in the lab
Manages the hospital transfers from area hospitals to the lab and back to transferring hospital

Fulltime

Sr. Associate IS Engineer

The IS Engineeris responsible for designing, developing, and maintaining softwar...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree and 3 to 7 years of Computer Science, IT or related field experience
Bachelor’s degree and 5 to 9 years of Computer Science, IT or related field experience
Diploma and 7 to 9 years of Computer Science, IT or related field experience
Hands on experience with Veeva Vault configuration
Proficiency in programming languages such as Python, JavaScript preferred or other programming languages
Strong understanding of software development methodologies, including Agile and Scrum
Solid understanding & Proficient in writing SQL queries

Job Responsibility

Possesses strong rapid prototyping skills and can quickly translate concepts into working code
Lead day to day operations and maintenance of Veeva Clinical Operations vault applications
Stay updated with the latest trends, advancements and standard process for Veeva Clinical Operations Vault applications
Design, develop, and implement applications and modules, including custom reports, interfaces, and enhancements
Analyze and understand the functional and technical requirements of Veeva Clinical Operations Vault applications, solutions and systems and translate them into software architecture and design specifications
Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software following IS change control and GxP Validation process
Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time
Maintain detailed documentation of software designs, code, and development processes
Work on integrating with other systems and platforms to ensure seamless data flow and functionality
Stay up to date on Veeva Vault Features, new releases and best practices

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Sr Associate Clinical Master Data Management

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