Associate Clinical Operations Manager 1

5 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, the person is responsible for Supporting budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals.

**Responsibilities include but are not limited to**:

- Support to country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close
- out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Support of Financial forecasting in conjunction with Sr.COM /other roles.
- Contribute to Execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Develops working knowledge of local language materials including local language Informed Consents and translations. May interact with IRB/IEC and Regulatory Authority for assigned protocols.
- Supports country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Contributes to the development of local SOPs.
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Provide support to local vendors as applicable.
- Support local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements. Enters and updates country information in clinical and finance systems.
- Support of local regulatory and financial compliance.
- Acquire knowledge how to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related
- interactions with support of an experienced COM. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Contribute to initiatives and projects adding value to the business, as appropriate/required.
- Contributes to COM team and other Country Operations roles knowledge by acting as/supporting process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement as appropriate/required.
- Contributes to COM team knowledge by sharing best practices as appropriate/required.

**Qualifications & Experience**:

- 1-2 years of experience in Clinical Research or experience in Finance/Business
- ** Required**:Associate degree or equivalent Health Care related experience
- ** Preferred**: Bachelor’s degree

**Skills Required**:

- Excellent verbal and written skills, in local language and English.
- Strong coordination and organizational skills.
- Basic knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-ups.
- Ability to propose solutions to local study teams.
- ICH/GCP knowledge appropriate to role. Hands on knowledge of Good Documentation Practices.
- Able to work with other experienced clinical research professionals to learn and develop skills to manage protocols independently. Works with high quality and compliance mindset.
- Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
- High sense of accountability and urgency in order to properly prioritize deliverables.
- Strong communication and negotiation skills in local language and English.
- Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
- Positive & growth mindset, capable of working independently and being self-driven.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R266925



  • 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...


  • 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...


  • 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 /...


  • Midrand, South Africa MSD Full time

    **Brief Description of Position** With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical...


  • Midrand, South Africa MSD Full time

    It is critical that, for all Organisation-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Associate CCQM position has an important impact in achieving those objectives. Under the guidance of the Regional Director, Clinical Quality Management (RCQM) and in...


  • 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...


  • 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,...


  • 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 or Clinical Research Director, the person ensures compliance of study conduct with ICH/Good Clinical Practice and country regulations, our company's policies and procedures, quality standards and adverse event reporting...


  • 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....


  • 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...


  • 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...


  • 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...


  • 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...


  • Midrand, South Africa MSD Full time

    **Brief Description of Position** 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 ICH/GCP and country regulations, the organization's policies and procedures, quality standards and adverse event reporting...


  • 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...


  • 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...


  • 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...


  • 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...


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

    Job Title: Executive Director, Clinical Research SAMNA Recruitment (Pty) Ltd is seeking an experienced Executive Director, Clinical Research SA to lead Clinical Operations for South Africa and the Sub-Saharan Cluster.Key Responsibilities:Lead the South African and Sub-Saharan Cluster Clinical Trial Operations leadership team, developing strategic plans to...


  • Midrand, South Africa MSD Full time

    **Brief Description of Position** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, organizational policies and procedures, quality standards and adverse event reporting...