Senior Clinical Operations Manager

5 months ago

Midrand, South Africa MSD Full time

This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company's policies and procedures and with quality standards internally and externally.
The person has ownership, oversight and impact on study operational activities and for out-tasking as applicable. Under the oversight of the CRD, the person is responsible to manage/oversee a team of Clinical Operations Managers (COMs) and/or Clinical Trial Co-ordinators (CTCs.)

**Responsibilities include, but are not limited to**:
Has significant impact on how a country or countries can deliver country-specific trial commitments and objectives especially during study start-up:
**LOCAL PROCESS OVERSIGHT**:

- Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management.
- Enters and updates country information in clinical, regulatory, safety and finance systems.
- Contribute or lead initiatives and projects adding value to the business, as appropriate/required.

**MANAGEMENT & QUALITY OVERSIGHT**:

- Responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to development of local/global SOPs.
- Oversees and trains CTCs and contract workers (e.g. CTCs) and local vendors and may manage COMs, both as applicable.

**FINANCIAL**:

- Working with Financial COM, takes ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Interacts successfully with local clinical team/s in order to deliver clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD is an option that can vary per country.

**COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS**:

- Responsible for oversight of clinical trial country submissions and approvals for assigned protocols, development of local language materials including local language Informed Consents and translations.

**COLLABORATION**:

- Works with mínimal oversight from CRD or COM manager in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM and CQM), Medical Affairs, PV, Regulatory Affairs, Business Compliance, MRL/Local finance departments, legal, HQ functional areas and externally with vendors and sites to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with Regional Operations and/or Headquarters to align country timelines for assigned protocols.
- Provides support and oversight to local vendors as applicable.

**Qualifications, Skills & Experience**
- ** Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.**
- ** Minimum 8 years of experience in clinical research.**
- Preferred: Master's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.
- Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners and country managers to deliver these commitments within specified timelines and budgets, with mínimal oversight from the line manager.
- Skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment and submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions.
- Extensive experience with clinical project management and coordination.
- Expertise of core clinical, regulatory and financial systems, tools and metrics.
- Extensive knowledge of local regulatory environment and submission and approval processes.
- Strong coordination and organizational skills.
- Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
- Demonstrates leadership behaviours.
- Problem solving and Process Improvement is essential to this position.
- Ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems i

  • Clinical Operations Manager

    5 months ago

    Midrand, South Africa MSD Full time

    This role is accountable for performance and compliance for assigned protocols in South Africa and Other African Countries in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the COM lead, Head COMs or CRD, you...

  • Clinical Operations Manager

    5 months ago

    Midrand, South Africa Edge Executive Search Full time

    Are you a dynamic leader with a passion for driving excellence in healthcare operations? Look no further! our client is seeking a talented individual to fill the crucial role of **Clinical Operations Manager.** As part of the dedicated team, you'll play a pivotal role in driving and implementing clinical operations functions across the dialysis units,...

  • Senior Clinical Trial Coordinator

    3 weeks ago

    Midrand, South Africa MSD Full time

    **Are you passionate about healthcare and innovation? Do you have a detail-oriented mindset and a desire to make a difference in people's lives? If so, we invite you to join us as a Senior Clinical Trial Coordinator. This vital role in our research & development division allows you to contribute directly to our premier mission of delivering innovative health...

  • Associate Clinical Research Manager

    5 months ago

    Midrand, South Africa MSD Full time

    With support of other Clinical Research Managers and/or Therapeutic Area Head/Clinical Research Director, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting...

  • Associate Clinical Operations Manager Ii

    6 months ago

    Midrand, South Africa MSD Full time

    **Brief Description of Position**: This role is accountable for performance and compliance for assigned protocols in **SOUTH AFRICA and OTHER AFRICAN COUNTRIES** in compliance with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight...

  • Associate Clinical Operations Manager 1

    6 months ago

    Midrand, South Africa MSD Full time

    **Brief Description of Position**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD,...

  • Clinical Research Manager

    2 months ago

    Midrand, South Africa MSD Full time

    This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...

  • Clinical Research Manager

    5 months ago

    Midrand, South Africa MSD Full time

    This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...

  • Clinical Research Manager

    6 months ago

    Midrand, South Africa MSD Full time

    This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...

  • Clinical Research Director

    3 weeks ago

    Midrand, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full time

    **Job Title:** Clinical Research Director**About the Role:** MNA Recruitment (Pty) Ltd is seeking a highly skilled Clinical Research Director to lead Clinical Operations for South Africa and the Sub-Saharan Cluster.The ideal candidate will have a deep understanding of clinical trials and a proven track record of leadership in the pharmaceutical...

  • Clinical Research Director

    4 weeks ago

    Midrand, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full time

    Clinical Research Director**Job Summary**MNA Recruitment (Pty) Ltd is seeking an experienced Clinical Research Director to lead Clinical Operations for South Africa and the Sub-Saharan Cluster. The ideal candidate will have a strong background in clinical trials, excellent leadership skills, and the ability to shape the clinical research landscape.**Key...

  • Clinic Manager

    6 months ago

    Midrand, South Africa International SOS Full time

    Clinic Manager / Head Nurse - Non Operational - Saudi Arabia As International SOS' footprint continues to grow in Saudi Arabia, continuous opportunities begin to arise for nurses with Clinic Manager experience. At this point in time, and as this is not an operational role, International SOS is looking for nurses with Clinic Manager experience that...

  • Clinical Leadership Position

    1 month ago

    Midrand, Gauteng, South Africa International SOS Full time

    Job Title: Clinic Manager / Head Nurse - Non Operational - Saudi ArabiaJob Summary: We are seeking a highly experienced Clinic Manager / Head Nurse to join our team in Saudi Arabia. The successful candidate will provide leadership and management of support for all Clinic activities, ensuring delivery of competent professional and operational services.Key...

  • Executive Director, Clinical Research SA

    2 months ago

    Midrand, South Africa MNA Recruitment (Pty) Ltd Full time

    A Global Pharmaceutical Company is seeking an Executive Director, Clinical Research South Africa and Sub-Saharan Cluster to join their team.As the Executive Director of Clinical Research, the individual will lead Clinical Operations for South Africa and the Sub-Saharan Cluster, overseeing all Clinical Trials. They will play a crucial role in shaping the...

  • Senior Clinical Trial Coordinator

    3 weeks ago

    Midrand, South Africa MSD Full time

    Join our team as a Senior Clinical Trial Coordinator (Safety Reporting) and be part of our mission to deliver innovative health solutions. This role is critical in ensuring comprehensive trial and site administration, primarily focusing on safety reporting. You will have the opportunity to collaborate closely with various teams and contribute to continuous...

  • Associate Country Clinical Quality Manager South

    6 months ago

    Midrand, South Africa MSD Full time

    Under the guidance of the Regional Director, Clinical Quality Management (RCQM) and in close collaboration with the Country Clinical Quality Manager (CCQM), the Associate CCQM supports the oversight of specific CQM activities in the respective country/cluster. The role requires the ability to properly support the implementation of local/global processes /...

  • Executive Director, Clinical Research South Africa

    2 months ago

    Midrand, South Africa MSD Full time

    Join our cutting-edge Clinical Research team that is dedicated to enhancing global healthcare through groundbreaking research and innovation. As the **Executive Director of Clinical Research**, you will spearhead Clinical Operations in **South Africa and the Sub-Saharan Cluster**, overseeing the execution of all clinical trials within the region. You will...

  • Clinical Research Associate Manager

    5 months ago

    Midrand, South Africa MSD Full time

    This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager the role is critical to...

  • Clinical Research Associate

    5 months ago

    Midrand, South Africa MSD Full time

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Pathologist

    6 months ago

    Midrand, South Africa IDEXX Full time

    IDEXX reference laboratories is a global network united by a shared commitment to enhancing pet care where the true strength in our name is the people behind it. Our reference laboratories make it possible for our customers to discover more with our unrelenting commitment to innovation, personalized support, guidance, and expertise, while providing the most...