Clinical Operations Manager

1 month ago


Bloemfontein, Orange Free State, South Africa Parexel Full time
About Parexel

Parexel is a leading global biopharmaceutical services company that supports clinical studies across various therapeutic areas. We have longstanding partnerships with a vast client base and have played a crucial role in the development of many top-selling drugs.

Job Summary

We are seeking a highly experienced Clinical Operations Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with ICH/GCP and country regulations, client policies, and quality standards.

Key Responsibilities
  • Prepare and submit local EC and RA submissions, including initial submissions and protocol amendments.
  • Independently prepare submissions to both EC and RA, with support from the CTC team for document collection.
  • Prepare ICF documents using templates.
  • Manage IMP supplies at the local level, including vendors providing background medications and standard of care.
  • Validate translated documents.
Requirements
  • Extensive experience in local EC and RA submission, including XML completion.
  • Experience in independently preparing submissions to both EC and RA.
  • Skilled knowledge of the local regulatory environment, submissions, and approval processes.
  • Understanding of how regulatory requirements impact study start-ups.
What We Offer

We care about our people and offer a supportive and open work environment where we empower individuals to develop their long-term careers. You will have the opportunity to develop within your role, tackle further responsibilities, or develop your skill set within other related departments of Parexel.



  • Bloemfontein, Orange Free State, South Africa Fokus Personnel CC Full time

    Clinical Opportunities ==================== Fokus Personnel CC is seeking a skilled Clinic Nurse to join our team. As a key member of our healthcare team, you will be responsible for providing high-quality patient care and working closely with our pharmacist to ensure the best possible outcomes for our patients. Responsibilities --------------- *...


  • Bloemfontein, Orange Free State, South Africa Parexel Full time

    About the RoleParexel is seeking a highly skilled Clinical Data Management Specialist to lead data management teams and deliver high-quality clinical study data.Key ResponsibilitiesDevelop and manage project timelines, ensuring timely delivery of data management tasks.Collaborate with cross-functional teams, including clinical research associates,...


  • Bloemfontein, Orange Free State, South Africa Parexel Full time

    About the RoleParexel is seeking a highly skilled Senior Clinical Data Analyst to join our team in South Africa. As a key member of our Clinical Data Management team, you will be responsible for leading and coordinating clinical data validation activities on assigned projects.Key ResponsibilitiesLead and/or coordinate all clinical data validation activities...


  • Bloemfontein, Orange Free State, South Africa Staff Unlimited Recruitment Pty Ltd TA MPC Recruitment Group EC Full time

    Position OverviewStaff Unlimited Recruitment Pty Ltd T/A MPC Recruitment Group EC is seeking a highly skilled Clinical Data Associate to join their team. This individual will be responsible for maintaining and improving performance and quality in data management services, including database set-up, CRF tracking, review, validation, and updating data in...


  • Bloemfontein, Orange Free State, South Africa Parexel Full time

    Parexel is currently recruiting for a Senior Clinical Data Analyst in South Africa.This role involves independently performing and/or coordinating all clinical data validation activities on assigned projects, with a high degree of proficiency and autonomy. Key responsibilities include providing technical expertise and/or operational leadership regarding all...


  • Bloemfontein, Orange Free State, South Africa Rectitude Recruit Full time

    Clinic Nurse Job DescriptionWe are seeking a skilled and compassionate Clinic Nurse to join our team at Rectitude Recruit. As a Clinic Nurse, you will play a vital role in providing high-quality patient care and supporting the pharmacist in delivering exceptional healthcare services.Key Responsibilities:Observe and interview patients to identify their care...


  • Bloemfontein, Orange Free State, South Africa Rand Mutual Admin Services Full time

    Job SummaryThe Clinical Rehabilitation Coordinator will be responsible for coordinating the delivery of clinical rehabilitation services to patients, including physical therapy, occupational therapy, and speech therapy. This role requires strong communication and coordination skills to ensure seamless care delivery and patient outcomes.Key...


  • Bloemfontein, Orange Free State, South Africa Fokus Personnel Full time

    We are seeking a highly skilled Clinical Healthcare Specialist to join our team at Fokus Personnel. As a Clinic Nurse, you will be responsible for providing exceptional patient care and support in our Pharmaceutical industry client's branch in Bloemfontein.Key Responsibilities:Provide vaccinations and other medical services to patientsConduct Pap Smears and...


  • Bloemfontein, Orange Free State, South Africa IQVIA Full time

    About the RoleWe are seeking a highly experienced Senior Clinical Auditor to join our team at IQVIA. As a key member of our Quality Assurance department, you will be responsible for conducting independent clinical audits to assess compliance with regulations, guidelines, and operating procedures.


  • Bloemfontein, Orange Free State, South Africa Parexel Full time

    Unlock Your Potential with ParexelThis is a hybrid position with travel 2/3 days a week to the sponsor's office in the region. As a member of our team, you will play a vital role in the success of our clients, including leading global biotechs and top 50 Pharma companies.Our Clinical Operations Manager (Regulatory) is responsible for the performance and...


  • Bloemfontein, Orange Free State, South Africa Parexel Full time

    Parexel: A Leading Provider of Biopharmaceutical Solutions We are a premier biopharmaceutical solutions organization, offering a wide range of services to support the development and delivery of innovative therapies.About the Role:As a Senior Regulatory Affairs Associate at Parexel, you will play a critical role in ensuring the timely performance of work...


  • Bloemfontein, Orange Free State, South Africa Parexel Full time

    Job SummaryAs a Clinical Research Associate II, you will be responsible for managing site quality and delivery from site identification through close-out. You will act as Parexel's direct point of contact with assigned sites, assessing and ensuring overall integrity of study implementation and adherence to study protocol at clinical sites.Key...

  • Clinical Technologist

    1 month ago


    Bloemfontein, Orange Free State, South Africa Bloemfontein Renal Services Full time

    Main Purpose of JobTo deliver high-quality patient care in the field of renal disease treatment and education, adhering to the Scope of Practice and Renal Care policies and standard procedures.Key ResponsibilitiesCollaborate with a multi-professional team to provide comprehensive patient care.Identify and manage risks to ensure patient safety.Create a...


  • Bloemfontein, Orange Free State, South Africa Staff Unlimited Recruitment Pty Ltd TA MPC Recruitment Group EC Full time

    **Clinical Data Associate - Job Overview**We are seeking a highly skilled Clinical Data Associate to join our team at MPC Recruitment Group EC. In this role, you will be responsible for maintaining and improving performance and quality in data management services, including database setup, CRF tracking, data validation, and study document development.**Key...


  • Bloemfontein, Orange Free State, South Africa Farm Manager SA Full time

    Key Responsibilities:Oversee all aspects of feedlot operations, including personnel management, cattle handling, and performance optimization.Ensure the maintenance of high-standard feedlot facilities.Requirements:Strong experience in cattle management and feedlot operations.Agricultural background and degree advantageous.Excellent stockmanship and...

  • Senior Data Team Lead

    3 weeks ago


    Bloemfontein, Orange Free State, South Africa IQVIA Full time

    Job Title: Senior Data Team Lead - Clinical Data ManagementAbout the Role:As a Senior Data Team Lead in our Clinical Data Management team, you will be responsible for independently managing end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.Key...


  • Bloemfontein, Orange Free State, South Africa Farm Manager SA Full time

    Are you a seasoned agricultural professional with a passion for feedlot operations? Do you have strong leadership skills and the ability to motivate a team? Farm Manager SA is seeking an experienced Feedlot Supervisor to oversee all aspects of our feedlot operations.The ideal candidate will have a strong background in cattle handling, good stockmanship, and...


  • Bloemfontein, Orange Free State, South Africa RECTITUDE RECRUIT Full time

    At RECTITUDE RECRUIT, we are seeking an exceptional Healthcare Professional to join our team as a Registered Clinic Nurse. As a key member of our healthcare team, you will be responsible for providing high-quality patient care and working closely with our pharmacist to ensure optimal treatment outcomes.Key Responsibilities:Observe and interview patients to...


  • Bloemfontein, Orange Free State, South Africa Staff Unlimited Recruitment Full time

    Our client, a specialized Contract Research Organization (CRO), is seeking a Data Management Specialist to join their team for a Clinical Research position. This role is responsible for maintaining and constantly improving performance and quality in data management services.Key Responsibilities:CRF tracking, set-up, and testing of databases for paper and...


  • Bloemfontein, Orange Free State, South Africa Farm Manager SA Full time

    We are seeking a highly skilled Feed Mill Supervisor to join our team at Farm Manager SA. The successful candidate will have a strong background in agriculture and experience working with machinery in large, automated mills.Key ResponsibilitiesOperate and maintain feed mills and related equipment, ensuring efficient and safe production.Supervise and...