Local Start-Up Senior Specialist

1 month ago

Chennai, India Allucent Full time

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote) The Local Start-up Senior Specialist (LSUS) coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this role your key tasks will include:

  • Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
  • Ensure planned dates are reliable and up to date in CTMS departments/study teams
  • File documents in the (e)TMF for which they are the document owner
  • Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner
  • Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level
  • Provide relevant documents in compliance with local regulation
  • Support review of technical, pre-clinical and clinical reports for regulatory submissions
  • Interact with regulatory authorities
  • Prepare and compile answers for questions raised by the regulatory agencies and submit the answers
  • Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate
  • Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed
  • Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level
  • Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation
  • Interact with IEC/IRB
  • Prepare and compile answers for questions raised by the IEC/IRB and submit the answers
  • Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate
  • Assist in adapting country SIS/ISF to site-specific requirements
  • Provide country specific requirements to GSCM impacting site contracts’ process
  • Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study
  • Negotiate within client approved contract and budget templates and negotiation parameters
  • Communicate with sites and internal personnel regarding the status of contracts and contract related document

Requirements

To be successful you will possess:

  • Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution
  • More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry
  • A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines
  • A thorough understanding of the drug development process
  • Good oral and written communications skills - fluency in English
  • Hands on experience on SUGAM portal
  • Understanding for local regulations (India) of NDAs/Vaccine/BABE/generic study
  • Experience with regulatory submission and follow ups

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.” #LI-JC1

  • Local Start-Up Senior Specialist

    1 month ago

    Chennai, India Allucent Full time

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Senior Specialist (LSUS)...

  • Globalization Specialist

    1 month ago

    Chennai, Tamil Nadu, India PowerSchool Full time

    OverviewPowerSchool is seeking a highly skilled and experienced Globalization Specialist to join our dynamic PowerSchool International team. As a Globalization Specialist, you will be responsible for the Localization of all PowerSchool portfolio of products targeting various countries across the globe.This position will play a significant role in building...

  • Study Start Up Associate I

    2 months ago

    Chennai, Tamil Nadu, India ICON Plc Full time

    Study Start Up Associate I & II ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our people that set us apart. Our diverse teams...

  • Localization Web Publishing Specialist

    4 weeks ago

    Chennai, Tamil Nadu, India Dotflick Solutions Full time

    At Dotflick Solutions, we are seeking a highly skilled Localization Web Publishing Specialist to join our team. This role plays a critical part in delivering world-class B2B Digital Marketing Experience to our prospects and customers.Job Description:We are looking for a seasoned professional with extensive experience in localization web publishing, AEM...

  • Localization Coordinator

    4 months ago

    Chennai, India Deluxe Full time

    Title: Localization Coordinator, Subtitling Business Unit: Deluxe Localization About the Company As the world’s leading multidisciplinary service provider, Deluxe underpins the media and entertainment industry, servicing content creators and distributors including Netflix, WarnerMedia, The Walt Disney Company, Amazon, Apple, Viacom, NBCU, Google, AT&T and...

  • Digital Platform

    6 months ago

    Chennai, India White Crystal Full time

    **Fintech (Finance Technology): - ** Product Manager, Chief Manager - Marketing, Marketing Manager, Business Development Manager, Marketing Executives. **Proptech (Property Technology): - ** Product Manager, Sales Manager, Property Technology Manager, Sales Executive **Commercial Rentals: - ** Customer Success Manager, Sales Manager, Sales Support...

  • Digital Platform

    7 months ago

    Chennai, India White Crystal Full time

    **Fintech (Finance Technology): - ** Product Manager, Chief Manager - Marketing, Marketing Manager, Business Development Manager, Marketing Executives. **Proptech (Property Technology): - ** Product Manager, Sales Manager, Property Technology Manager, Sales Executive **Commercial Rentals: - ** Customer Success Manager, Sales Manager, Sales Support...

  • Senior Lead Generation Specialist

    3 months ago

    Chennai, India Ciklum Full time

    Ciklum is looking for a Senior Lead Generation Specialist to join our team full-time in Chennai.We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over 4,000 highly skilled developers, consultants, analysts and product...

  • Quality Control

    6 months ago

    Chennai, Tamil Nadu, India Newgen knowledge works Full time

    We are recruiting for a Senior QA Executive who is willing to work in rotation shifts (including night shifts). 1. Ability to work in Multilanguages QA. 2. Should be knowledge in Localization 3. Ability to work especially in Arabic, Farsi and Hebrew languages 4. Good knowledge in handling QA in European and Asian languages. Pay: ₹20,000.00 -...

  • Senior Lead Generation Specialist

    1 month ago

    Chennai, India Ciklum Full time

    Ciklumis looking for aSenior Lead Generation Specialistto join our team full-time in Chennai.We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over 4,000 highly skilled developers, consultants, analysts and product owners, we...

  • Senior Lead Generation Specialist

    3 months ago

    Chennai, India Ciklum Full time

    Ciklum is looking for a Senior Lead Generation Specialist to join our team full-time in Chennai. We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over 4,000 highly skilled developers, consultants, analysts and product...

  • Senior Lead Generation Specialist

    3 months ago

    Chennai, India Ciklum Full time

    Ciklum is looking for a Senior Lead Generation Specialist to join our team full-time in Chennai.We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over 4,000 highly skilled developers, consultants, analysts and product owners,...

  • Senior Lead Generation Specialist

    3 months ago

    chennai, India Ciklum Full time

    Ciklum is looking for a Senior Lead Generation Specialist to join our team full-time in Chennai.We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over 4,000 highly skilled developers, consultants, analysts and product owners,...

  • Senior Lead Generation Specialist

    3 months ago

    Chennai, India Ciklum Full time

    Ciklum is looking for a Senior Lead Generation Specialist to join our team full-time in Chennai.We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over 4,000 highly skilled developers, consultants, analysts and product owners,...

  • Senior Treasurer

    2 weeks ago

    Chennai, Tamil Nadu, India Staffing Solutions Full time

    Job OverviewWe are looking for a Senior Treasurer who can lead our banking specialist team at Staffing Solutions. As a seasoned professional, you will be responsible for managing foreign exchange operations and ensuring compliance with local regulations.About the JobThis role requires strong analytical and problem-solving skills to operate in ambiguous...

  • Ciklum | Senior Lead Generation Specialist

    4 weeks ago

    Chennai, India Ciklum Full time

    Ciklumis looking for aSenior Lead Generation Specialistto join our team full-time in Chennai.We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over 4,000 highly skilled developers, consultants, analysts and product owners, we...

  • Senior Piping Layout Specialist

    4 weeks ago

    Chennai, Tamil Nadu, India Bechtel Corporation Full time

    About Bechtel CorporationWe are a global leader in the delivery of complex infrastructure projects. Our expertise spans from initial planning and investment, through start-up and operations.Job SummaryWe are seeking an experienced Senior Piping Layout Specialist to join our team in Chennai. This role will involve designing and implementing piping systems for...

  • Senior Lead Generation Specialist

    1 month ago

    Chennai, India Ciklum Full time

    Ciklum is looking for a Senior Lead Generation Specialist to join our team full-time in Chennai. We are a custom product engineering company that supports both multinational organizations and scaling startups to solve their most complex business challenges. With a global team of over 4,000 highly skilled developers, consultants, analysts and product...

  • Senior Subcontracts Specialist

    8 months ago

    Chennai, India McDermott International Full time

    Job Overview: The Senior Subcontracts Specialist uses best practices and knowledge of internal or external issues to improve the subcontracts discipline within McDermott. They will act as a resource for colleagues with less experience and share their conceptual and practical expertise related to the subcontracts discipline. The Senior Subcontracts...

  • Marketing specialist

    1 month ago

    Chennai, India Fasta Pizza Full time

    Company Overview: We are a rapidly expanding pizza venture committed to establishing a significant presence in the community and beyond. Our company, Fasta Pizza, produces exceptional-quality pizza. To establish and promote our brand through effective and efficient offline strategies, we seek a Marketing Specialist with a proven track record in the food...