Clinical Operation Manager

2 weeks ago

Centurion, South Africa IQVIA Full time

**Job Overview**

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

**Essential Functions**
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
- identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.

**Qualifications**
- Bachelor's Degree Life sciences or related field Req
- 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
- Strong negotiation and communication skills with ability to challenge
- Excellent interpersonal skills and strong team player
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
- Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Good regulatory and/or technical writing skills
- Good leadership skills, with ability to motivate, coach and mentor
- Good organizational and planning skills
- Ability to exercise independent judgment taking calculated risks when making decisions
- Good presentation skills
- Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Excellent understanding of study financial management
- Proven ability to work on multiple projects balancing competing priorities

  • Clinical Operation Manager

    4 weeks ago

    Centurion, South Africa IQVIA Full time

    You will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role may also include maintenance activities. This is not a line management position but requires...

  • Clinical Trial Assistant

    6 days ago

    Centurion, South Africa IQVIA Full time

    **Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution,...

  • Snr Clinical Trial Assistant

    4 weeks ago

    Centurion, South Africa Novasyte Full time

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

  • Consultant: Clinical Auditor

    4 weeks ago

    Centurion, South Africa PPS Recruitment Full time

    **Job Advert Summary**: Applications are invited for the above-mentioned position, to be filled as soon as possible. **Minimum Requirements**: - Nursing qualification. - Clinical Auditing experience - Minimum of 2 years' experience in the managed care environment **Duties and Responsibilities**: - Conduct clinical audits on claims and costs to ensure...

  • Senior Clinical Research Associate II

    4 weeks ago

    Centurion, South Africa Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Senior Clinical Research Associate Ii

    4 weeks ago

    Centurion, South Africa Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Research Associate

    4 weeks ago

    Centurion, South Africa IQVIA Full time

    **Job Overview** Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. **Essential Functions** - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...

  • Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA

    2 weeks ago

    Centurion, South Africa IQVIA Full time

    Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

  • Operational Effectiveness Director

    4 weeks ago

    Centurion, South Africa Novasyte Full time

    Job Overview Essential Functions - Recommend strategic programs forming long-term business partnerships maximizing the creation of global solutions that accelerate operational process/productivity improvements within IQVIA positively impacting data capture, project planning, change/data/process management, data compilation and high quality deliverable...

  • Senior Operations Manager

    6 days ago

    Centurion, South Africa H2R Full time

    Gauteng, Centurion - Market related - Market related Monthly Cost To Company (Market related) A large Medical Health Care facility in the East of Pretoria has a contract vacancy for a Senior Operations Manager with the possibility of becoming permanent after 12 months. To provide leadership and manage various operational teams to ensure the achievement and...

  • Concierge

    4 weeks ago

    Centurion, South Africa META-CLINIC ELARDUSPARK Full time

    WE ARE HIRING //We are expanding our national footprint and looking for concierges to join our team at META-CLINIC Pretoria.The following are the duties and responsibilities required by the concierge to ensure the smooth and effective operation of Meta-Clinic: Manage the opening and closing of Meta-Clinic, including locking the facility. Ensure accurate...

  • Pharmacy Manager

    7 days ago

    Centurion, South Africa Clicks Group Limited Full time

    **Position Summary**: **Industry**:Wholesale & Retail Trade - **Job category**:Pharmaceutic**Location**:Centurion - **Contract**:Permanent**Remuneration**:Market Related - **EE position**:Yes**Brand**:Clicks Group**Introduction**: To ensure the efficient operation of the dispensary and the clinic and to ensure service excellence by leading and directing the...

  • Laboratory Project Services Manager

    4 weeks ago

    Centurion, South Africa Novasyte Full time

    Job Overview Under general direction, manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer, drug program, indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study lifecycle...

  • Assistant Pharmacy Manager

    5 days ago

    Centurion, South Africa Medipath Healthcare Recruitment Full time

    **18th March, 2023**: **Responsibilities**: - Deliver effective pharmaceutical care in both hospital and retail environments. - Ensure effective management of patient pharmaceutical care in the absence of the Pharmacy Manager and the Operational Assistant Pharmacy Manager. - Maintain pharmaceutical standards, quality assurance, and risk management within...

  • Site Activation Manager

    4 weeks ago

    Centurion, South Africa Novasyte Full time

    Site Activation Manager Global Site Activation - GSA The GSA unit within IQVIA has the vision to be the clear market leader in clinical trial site activation, driving best in class employee, site and customer experiences and we are looking for passionate people to join our team. The Site Activation Manager (SAM) position within GSA team in IQVIA is our...

  • Service Manager

    4 weeks ago

    Centurion, South Africa PPS Recruitment Full time

    **Job Advert Summary**: **Minimum Requirements**: - A minimum of a Grade 12 and Registered Nursing qualification. - Sound Clinical knowledge. - Exposure to Managed HealthCare policies and procedures, ISO principles and other related legislature would be an added advantage. - Ability to effectively communicate at all levels. - Computer literacy (MS Office...

  • Aesthetic Manager

    4 weeks ago

    Centurion, South Africa MF Spa & Beauty Placements Full time

    **AESTHETIC MANAGER - Laser & Aesthetic practice experience** **Centurion** - Gauteng, South Africa (ZA) **Starting Date**: A.S.A.P / November 2023 **Report to**:Salon Owner **TRADING HOURS & SHIFTS** - Monday to Friday 08:00 - 18:00 (9-hour shift) - Saturdays 08:00 - 16:00 - CLOSED on Sundays **PACKAGE POTENTIAL & BENEFITS**: - Market-related Salary /...

  • Operations Manager

    7 days ago

    Centurion, South Africa Momentum Life Full time

    **Introduction** The Operations Manager function is aimed to provide a variety of management and professional support outcomes, across the Product, Operations and Implementation focus areas, with an emphasis on people, process and technology performance management. Operational Excellence, efficiency and digital transformation are key strategic objectives...

  • Operations Manager

    4 weeks ago

    Centurion, South Africa H2R Full time

    Gauteng, Centurion - R 100 - R 200 Monthly Basic Salary (Negotiable) Our client, in the RISK SOLUTIONS field has a Contract to become permanent vacancy for a Operations Manager with RE1 and RE5 experience. The Operations Manager is responsible for strategy development for the effective operation of the insurance company. He/she must manage the operational...

  • Consultant:disease Risk Management

    4 weeks ago

    Centurion, South Africa PPS Recruitment Full time

    **Job Advert Summary**: Applications are invited for the above-mentioned position, to be filled as soon as possible. **Minimum Requirements**: **Qualifications & Experience** - Grade 12 - A Registered Nursing qualification - Disease Risk Management is essential - Sound knowledge of the Coding Systems: ICD10 & CPT4 Principles and sound knowledge of the...