Premier Research is looking for a Associate Data Manager - FS to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What we are searching for: Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan Provide input to and review of Data Management Plans in support of clinical study deliverables Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required Assists in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements Prepares and maintains documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required What we are searching for: Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience 3 to 5 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

Premier Research is looking for a Senior APAC People Partner to join our People Partners team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What Youll Be Doing : Partners closely with the lead Functional Strategic People Partner to provide regular updates relating to all matters within the APAC region Partners with APAC people managers to support with performance issues, succession planning, operational strategies etc Employee relations Supports People Services annual processes such as performance reviews, talent management, learning and development, and compensation/benefit reviews within the APAC region Supports, where required, the Talent Team throughout recruiting lifecycle to ensure the hiring of top talent. Responsible for APAC countries human resources compliance; monitors and implements local requirements; maintaining records; audits on regular basis to ensure compliance; ensures adherence to local policies, procedures, and reporting requirements Proactively identifies, analyzes, and improves existing country or regional business processes for optimization and improved business outcomes Supports programs and partners with APAC people managers to deliver strategies to drive engagement and retention and reduce attrition; consults with Functional Strategic People Partners and provides solid recommendations on people solutions to improve business outcomes. Utilizes internal and external data, market trends and analysis of people metrics to drive APAC data-driven insights around attrition, growth, and retention to identifying opportunities Supports and implements People Services initiatives created by the Centers of Excellence; shares data and makes recommendations to improve programs or implementation of plans What We Are Searching For : Bachelor s degree or its international equivalent or equivalent experience gained in the HR field; PHR/internationally recognized HR qualification/ certification preferred Minimum 8 years country HR experience or 5 years multi-country HR experience. Very strong knowledge of most functional areas of HR, local employment law, and employee relations. Must have prior global and / or US company experience. Must be located within commuting distance of our Bangalore office as this role has a requirement to be a hybrid set up.

Premier Research is looking for a Data Coordinator - DM to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What youll be doing: Assists in testing of databases (DBs) and maintenance of study data, including the processing of discrepancies and queries. Reviews Case Report Forms (CRFs), data listings, and DBs to ensure that all captured data follow the rules outlined by the protocol, CRF Completion Guidelines (CCGs) and departmental plans. Collaborates cross-functionally with colleagues to ensure the integrity of clinical databases. Prepares documentation, such as CCGs, Data Management Plan (DMP), Data Report Assists in developing standard test data for testing screens and listings and provides feedback on the results of the testing Performs user acceptance testing on studies, including testing of edit checks, etc. Assists in maintaining DBs and supports DB updates Performs data entry Generates reports for data review Reviews CRFs, data listings, and DBs to ensure all data captured follow protocol, CCGs, DMP, etc. Generates queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data identified during various aspects of the data management (DM) process Reviews responses to queries and resolves discrepancies Performs external data and/or serious adverse event reconciliation Acts as a Lead Data Coordinator and/or Safety Reviewer on multiple studies Performs document submission to Trial Master File (TMF) Supports TMF Quality Control (QC) activities Performs database QC activities Performs QC of study reports, CRF archive files Supports the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status What we are looking for: Bachelor s Degree or above (preferably in a Life Science) Typically requires 2 -4 years of DM mastery or related clinical research industry experience Knowledge of at least one Clinical Data Management System (CDMS) (e.g. Medidata Rave, Calyx EDC, etc.)

Premier Research is looking for a Senior, Clinical Payment Specialist I to join our Procurement and Vendor Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What youll be doing: The Senior Clinical Payment Specialist I (Sr. CPS I) is a finance subject matter expert that supports study teams with moderately complex and diverse site finance activities including, but not limited to, investigator grant payments, accruals, and forecasting. The Sr. CPS I performs study setup, site contract setup, site payments, invoice reconciliation, forecast and accrual generation, and other varied and intricate finance activities within dedicated finance systems. The Sr. CPS I also administers the finance systems by managing account accesses and troubleshooting and resolving a wide range of issues in creative ways. This role is responsible for conducting training for the Clinical Payment Specialist I/II positions (CPSs) and may act as an escalation point of contact for CPSs and study teams. The Sr. CPS I may participate in process definition and SOP development. This position works on problems of diverse scope where analysis of data requires evaluation of identifiable factors and demonstrates good judgment in selecting methods and techniques for obtaining solutions. Facilitate and distribute grant payments to respective sites throughout the course of a study and effectively communicate with investigators, sponsors, and internal/external study team members Ensure moderately complex clinical studies are correctly and appropriately set-up in the required system(s) as per the scope of work Ensure finance activities are completed within timelines as per service level agreements Provide direction according to established policies and management guidance Review study specifications (e.g. - EDC visit and procedure structure) and site contracts to understand and implement system setup requirements accordingly Complete setup in finance system(s) based on information in study specifications and site contracts Process data within finance system, ensuring accurate payment, forecasting, and accrual outputs Identify and work with clinical team to follow up on difficult invoice discrepancies, past due invoices, and to request refunds from sites Produce and analyze reports, as needed, outlining payment, forecasting, and accrual activity Works on issues of diverse scope that require strong judgment and decision-making skills Provide system support to clinical study teams throughout the life of the study and shows strong judgment within defined policies and procedures Recommends changes to sub unit policies Train and develop those in the Clinical Payment Specialist II position Networks with senior internal and external personnel Additional activities as delegated What we are looking for: Bachelor s degree, or its international equivalent from an accredited institution, in a finance, Clinical, science or health related field; or related experience BS/BA and 5 years direct experience, or 5+ years of related experience in site finance Activities and/or clinical trial finance No experience managing people or processes required Prior experience using computerized information systems Proven experience analyzing and interpreting site contracts and budget terms Experience working with various systems such as: EDC, CTMS, IVRS and other clinical systems Knowledge of ICH and local regulatory authority drug research and development regulations Strong analytical and investigative skills

Premier Research is looking for a Clinical Trial Associate II to join our Global Clinical Monitoring and Site Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. Document Management Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) in collaboration with the clinical team as defined by the organizations or Sponsor s SOPs and all applicable regulatory requirements. Creates and maintain placeholders in the TMF based on TMF filing plans, expired documents, study milestones, site staff changes, and other applicable events. Reviews site documents and verifies they meet or exceed all company, sponsor, regulatory authority, and ALCOAC standards. Performs Quality Review and completeness checks of relevant eTMF sections in compliance with company or Sponsor processes throughout start up, maintenance, and close out activities and ensures follow up with clinical team of resolution of findings. Conducts follow up with the internal team on TMF queries to ensure timely resolution. Routinely runs and distributes eTMF reports to clinical team to facilitate quality and compliance. May assist SSUAs/CRAs with essential document collection and review during startup, maintenance and close out. May support the translation of site documents or reviews translations of site documents, if required. Data entry, Tracking, Reporting and System Support Assists the clinical team with CTMS set up and data entry into project tracking systems, as applicable, including but not limited to site contact updates, site address updates, maintain site assignments and site activation activities, e.g. vendor activities. Assists the clinical study team in the tracking and documentation of Investigators Brochure and safety report distribution as well as other documents/materials sent to sites, e.g. newsletters. Assists with managing and tracking access to systems, (i.e. CTMS, Vendors, EDC, IWRS, etc.) for site staff and clinical team; including conduct of routine reviews, to ensure access removal. Reviews the project specific training matrices and reports to ensure compliance of clinical team. May create CRA workflows to manage site follow up items. Other Attends internal clinical meetings as required and assist with meeting preparation and follow up (decisions, actions, issue logs). Supports the CRA/clinical team in liaising with third party vendors to solve and follow-up on issues e.g. on study equipment, translations. Supports other study specific tracking, such as Q&A log. Participates in available internal training offered to increase therapeutic knowledge. Assists the clinical team with the development of study material, such as create Investigator/Pharmacy site files in collaboration with the study team before Site Initiation Visit; includes working with vendor for creation and distribution of ISF Binders (upload documents, review proofs, trigger shipments). Coordinates general office logistical activities as requested May mentor and train less experienced CTAs May be a point of contact for IT issue resolutions Identifies, manages, escalates issues where appropriate and collaborates with Project Team and Line Manager to identify solutions. May participate in departmental initiatives. Performs additional duties and assignments as required.

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. Location: Home-based What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells. Performs quality control (source code review, double-programming and log review) of SAS programs. Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications. Prepares specifications for CDISC and other analysis data sets. Assists Data Management with SAS programming needs. Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team. Develops and validates general SAS macros. What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work-related experience to be able to perform this role. 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

Job Description In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells Performs quality control (source code review, double-programming and log review) of SAS programs Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Prepares specifications for CDISC and other analysis data sets Assists Data Management with SAS programming needs Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team Develops and validates general SAS macros What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

Premier Research is looking for a Associate Data Manager - FS (4 month fixed-term contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What we are searching for: Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan Provide input to and review of Data Management Plans in support of clinical study deliverables Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required Assists in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements Prepares and maintains documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required What we are searching for: Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience 3 to 5 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells Performs quality control (source code review, double-programming and log review) of SAS programs Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Prepares specifications for CDISC and other analysis data sets Assists Data Management with SAS programming needs Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team Develops and validates general SAS macros What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

Location: India Shift timing: 12 Pm to 9 Pm IST What you will be doing: The Application Services Engineer will assist with providing technical support and technical administration of Premier's corporate and clinical applications including: Resolving end user issues in specialized systems through a ticketing system while meeting SLAs put in place by the Technology leadership team and the business Assist with system upgrades and patches as needed with properly documented test cases Assist with integration requirements, building, testing and documentation to provide required system data for consumption by other applications Ability to build and run SQL scripts to identify data problems and help provide recommended solutions Ability to design and build xml-based Web service integrations (SOAP and REST) to integrate enterprise systems Development and maintenance of documentation for business processes supported by the systems and integration points/requirements Creation of knowledge base articles that can be added to the help section the corporate IT Service Management system Setup of security models for supported systems as well as assists as needed with audit requests Assist senior team members with projects while keeping project team members, stakeholders, vendors, and senior IT management informed of issues and overall status What we are searching for: Bachelor's degree and 1-2 years IT experience supporting enterprise level applications, preferably in a life sciences-based company, or an equivalent experience of 2-4 years with demonstrated experience in corporate application administration. Experience of technical support/administration of corporate applications that utilize an application frontend and database backend. Finance, Human Resources, Clinical, Corporate Reporting systems experience preferred. Core systems include Workday, Salesforce, OneStream, Freshworks, Argus, Cornerstone, Ideagen - iQM, Smartsheet, other corporate and clinical applications as required. Experience supporting corporate application modules within a team environment Understanding of Web services and integration mechanisms, XML and/or XSLT experience is desired Oracle and SQL Server database administration is a plus Fluent verbal and written English Excellent team player; collaborative and consensus builder Ability to multitask and work effectively in a fast-paced environment with changing priorities Strong verbal and written communication and negotiation skills Excellent organizational and time-management skills, able to prioritize work to meet deadlines Strong desire to learn new skills and expand technical experience Accountable, dependable, and strong commitment Customer service focused approach to work both internally and externally Maintains a positive, results orientated approach Ability to work both independently and in a team environment