Clinical Data Lead

2 weeks ago

Johannesburg, Gauteng, South Africa ICON plc Full time
At ICON, it's our people that set us apart.

Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.


Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity.

We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point.

In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us.

You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.


Clinical Data Lead

_ Role is South African based - remote working or office based_


This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.


  • The point of contact for day to day activity on a study with key responsibilities for study setup and closeout tasks as well as overseeing and coordinating tasks delegated to the study team members both locally and in other offices.
  • Coordinate with data management teams, studies and programs of studies and independently oversee the performance of data management activities on multiple studies.
  • Reporting to the Project Manager I Sr. Project Manager, Data Management.

Overview of the Role

  • Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 10%) domestic I international.
  • Read, ensure understanding and adhere to all assigned ICON/Client SOPs and working procedures.
  • Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
  • Complete all assigned training (including the COL Development Program) and courses in the ICON Training Management system (iLearn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies.
  • Record all billable and nonbillable time in the appropriate timesheet management system (e.g. Planview).
  • Independently prepare all materials and take part in study kick off (internal and external) meeting.
  • Read, ensure understand ing and adhere to the study protocol, contract and scope of work for all task during setup, maintenance and closeout of the study.
  • Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract analyst.
  • Independently compile the change order log and distribute internally as per ICON's change order process.
  • Demonstrate an understanding of the revenue recognition and revenue forecasting process by independently performing revenue recognition and revenue forecasting process on a monthly basis.
  • Lead the development of specifications, implementation, and testing for the eCRF or paper CRF.
  • Lead the development of specifications, implementation, and testing for the edit checks and data review and oversight listings (DVS).
  • Lead development of the data management plan and study specific procedures.
  • Ensure effective implementation of standard metric and status reporting on the study.
  • Lead development of specifications for custom reporting on the study.
  • Independently perform project planning tasks and develop the project plan and timelines.
  • Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors.
  • Adhere to ICON/Client SOPs, the Data Management Plan, Working procedures and study specific procedures in the implementation of tasks on the study.
  • Adhere to the project plan and timelines in the implementation of study tasks during setup, maintenance and closeout of the study.
  • Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components.
  • Independently attend and provide an update for data management services at cross
- functional study team meeting both internally and with the sponsor.

  • Maintain and track meeting minutes, issues and decisions logs, and escalations.
  • Independently negotiate the time lines and make study level decisions.
  • Provide regular study status updates to the DMPM.
  • Support the DMPM in the d

  • Senior Clinical System Lead

    2 weeks ago

    Johannesburg, Gauteng, South Africa Icon plc Full time

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development...

  • Clinical Data Co-ordinator

    2 weeks ago

    Johannesburg, Gauteng, South Africa ICON plc Full time

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • Clinical Lead Generation Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Mindful Care Full time

    Position Summary:Mindful Care is excited to extend an invitation to a dedicated and self-driven Clinical Lead Generation Specialist to join our team. The Clinical Lead Generation Specialist at Mindful Care is a unique role that sits at the intersection of clinical intake and business development, initiating relationships with the medical community to build...

  • Clinical Lead Generation Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Mindful Care Full time

    The Company:Person by person, we believe we can reimagine mental healthcare for everyone, at any point in their lives. We are a human potential brand—obsessively focused on guiding the individual toward comprehensive mental healthcare, and being an ally to everyone no matter where they are. We compete on frictionless urgent access to affordable mental...

  • Hiv Clinical Data Capturer

    2 weeks ago

    Johannesburg, Gauteng, South Africa Palesa Mbali Group Full time

    The Clinical Data Capturer works within the Aid for Aids space and is responsible for efficiently and accurately interpret and capture clinical data to support the relevant stakeholder's needs and demands thus supporting the organisation's customer service image and brand.Key Activities: Accurately and efficiently interpret and data capture, the required...

  • ERP Data and Reporting Lead

    2 weeks ago

    Johannesburg, Gauteng, South Africa Data Centrix Full time

    Requirements: 8+ years' experience in SAP with a specialty in Finance and/or Procurement solutions. Experience as Data Lead on multiple largescale SAP implementations (Ariba cloud experience preferred). Strong understanding of security role design, user provisioning processes and data security / classification. At least 3 full lifecycle SAP implementation...

  • Clinical Medical Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa Novo Nordisk Full time

    Clinical Medical ManagerCategory:Medical AffairsLocation:Johannesburg, Gauteng, ZA-The Position As a Clinical Medical Manager, you will facilitate the execution of clinical trials related to New Therapy Areas (including Cardiovascular Disease (CVD), Nephrology, Hepatology and Alzheimer's disease) by providing medical/scientific expertise and advice based on...

  • Clinical Medical Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa Novo Nordisk AS Full time

    Are you interested in a role where you can apply your medical expertise to engage with medical experts globally and convey scientific information? Are you enthusiastic about the realm of clinical trials? Are you driven by the opportunity to impact patients' lives positively? If so, we have an exciting opportunity for you as a Clinical Medical Manager. Take...

  • Clinical Quality

    2 weeks ago

    Johannesburg, Gauteng, South Africa Novo Nordisk Full time

    Would you like to be part of our Clinical Development Center South Africa (CDC-ZA) management team as we set out on a journey into new and exciting therapeutic areas and ways of working? Can you help us bring new treatments to patients, faster and smarter by leading and optimizing clinical quality and training? Then you could be our new Clinical Quality &...

  • Clinic Advisor

    2 weeks ago

    Johannesburg, Gauteng, South Africa SD Recruitment Full time

    Locum CPT00027 Medical Industry Gauteng, JHB CentralSd Recruitments is looking for a Registered Nurse to assist a Clinic Manger to effectively manage the clinic's administration for all The Local Choice Clinics and its employees while ensuring the organizationcomplies with industry standards and regulations.Working conditions: (travel, work space, etc.)Be...

  • Clinical Operations Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa ICON plc Full time

    Clinical Operations Manager (COM)South Africa, HomebasedAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an...

  • Clinical Advisor

    2 weeks ago

    Johannesburg, Gauteng, South Africa 3Sixty Health (Pty) Ltd Full time

    3Sixty Health has a great opportunity for a suitably qualified individual to fulfil the advertised position and join their team.3Sixty Health is a black owned and managed, reputable and a major player in driving SouthAfrican economy by investing in ''black excellence''3Sixty Health is 100% black owned and black managed administrator as well as Managed...

  • Clinical Trial Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa ICON Full time

    Clinical Trial ManagerLocation - hybrid (Johannesburg, South Africa)Sponsor dedicatedAs a Clinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organizations, powered by healthcare intelligence.As a single sponsor-dedicated Clinical Trial Manager, you will have an opportunity to work in a solid partnership and...

  • Hospital Clinical Coder

    2 weeks ago

    Johannesburg, Gauteng, South Africa Mass Staffing Projects Full time

    On the hunt for something new? Looking for a Hospital Clinical Coder in Johannesburg to be responsible for assessing patient's clinical statements, assigning standard codes and resolving coding queries.Requirements: Intermediate level certificate in intermediate clinical coding essential Registered as an Enrolled Nurse Sound financial knowledge and the...

  • Clinical Quality Training Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa Novo Nordisk AS Full time

    Are you passionate about clinical quality and training? Do you want to be part of a team that brings new treatments to patients faster and smarter? We are looking for a Clinical Quality Training Manager to join our SEMEEA Clinical Development Centre (CDC) leadership team. If you are ready for an exciting journey into new therapeutic areas and ways of...

  • Clinical Quality Training Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa Novo Nordisk Full time

    The position As a Clinical Quality Training Manager, you will play a crucial role in ensuring high-quality clinical trials and training within the CDC. In addition, you will be responsible for cascading down the global quality focus targets and areas to the CDC level, managing the risk, escalating issues and providing guidance to the clinical team,...

  • Clinical Medical Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa Novo Nordisk Full time

    The positions are mainly field based creating visibility to the sites and connecting science with to the related therapeutic area.The field means across South Africa, but preferably the person is based in Johannesburg for easy access to our office, working closely with our clinical trials and medical team.We are recruiting for 4 Clinical Medical Managers,...

  • Clinical Operation Excellence Head

    2 weeks ago

    Johannesburg, Gauteng, South Africa Novo Nordisk Full time

    Clinical Operation Excellence HeadCategory:Clinical DevelopmentLocation:Johannesburg, Gauteng, ZA- Come be part of our team as we embark on an exciting journey of growth Make a real impact with us at our growing Clinical Development Centre in South Africa (CDC-ZA).- We're on a mission to make groundbreaking advancements in the field of medicine once again...

  • Data Capturer Vacancies In Cape Town – Clinical Research Associate

    2 weeks ago

    Johannesburg, Gauteng, South Africa Ppd Full time

    Job Description:The Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and Sponsor's SOPs. The CRA conducts site visits to assess protocol and regulatory compliance and manages required documentation and ensures that data...

  • Clinical Call Centre Agent

    2 weeks ago

    Johannesburg, Gauteng, South Africa Palesa Mbali Group Full time

    Position:Clinical Call Centre AgentPosition Purpose:To provide professional customer service to Business unit members and brokers by ensuring that all call centre queries are handled to set performance standards at all times and ensuring prompt resolution of clinical queries within the Non-Clinical Authorisations queue.Experience:2 - 3 years clinical call...