Clinical Operations Study Country Lead

7 days ago

Pretoria, Gauteng, South Africa Clinical Research Training Academy Full time

About The Job

Clinical Operations Study Country Lead (COSCL) is the country level operational lead in clinical studies. He / she owns, and is accountable for, the strategic planning, management and performance of their assigned clinical trials, for his / her country(ies), from country allocation until study closure at the Clinical Study Unit (CSU) level including study country timelines, study country budget, and study conduct in accordance with Sanofi Standard Operating Procedures (SOPs) and / or Quality Documents (QD)s and ICH / GCP and regulatory guidelines & directives.

The COSCL is the key strategic interface, at country level, with internal and external stakeholders to manage operational processes to accelerate trial conduct. Key Interfaces for COSCL are:

  1. Globally: Clinical Operations Study Lead (COSL), Data Management, Vendor Management, Study Medical Manager, Clinical Supply Chain Study Manager, Patient Recruitment and Retention Lead and other Core Study Team members / transversal roles.
  2. Locally: Clinical Research Associate (CRA), Clinical Project Assistant (CPA), Medical Advisor (MDA), Site Engagement Lead (SEL), Strategic Start Up Manager (SSUM), Medical Science Liaisons (MSL) and other relevant roles.

COSCL represents their CSU at the Core Study Team meetings.

COSCL reports to CSU Team Lead or CSU Head in their given CSU country, while working closely functionally with COSLL for study topics. While the COSCL may consult COSL or escalate on operational issues that could affect study costs, speed or quality in the CSU, the COSCL is fully accountable to deliver the study as planned in their CSU level.

Main Responsibilities Include:

  1. Set up local study country strategy and lead country start up activities: Develop and initiate early recruitment and retention strategy and associated materials at local level in collaboration with respective colleagues, identify most successful site mapping and set up site engagement strategy aligning with SEL and MDA, organize the local kick off meeting and lead set-up activities to ensure progress according to study timelines with strategic planning.
  2. Lead local study management at CSU on execution of clinical studies according to global and local study plan: Fully own the local level performance of the study, ensuring the study is conducted in compliance with planning and agreed timelines. Accounts for the set-up, completion, and adaptations of project management tools at country level (CTMS, Control room…). Drive performance of the study with risk assessment and mitigation strategies, manage sites engagement aligning with SEL (Site Engagement Lead) and MDA (Medical Advisor) regarding site motivation and provide support to site staff and monitoring team in the conduct of clinical trials.
  3. Own Study Budget at country / cluster level and ensure optimization and appropriate management of the financial resources: Collaborate with Start Up Strategic Manager (SSUM) for preparation of Local Study Cost Request (LSCR) ensuring cost optimization and appropriate projection at the beginning of the study. Manages and maintains Country Study Budget during course of study, ensures timely escalation of issues / risks related to the country budget and initiate LSCR updates.
  4. Lead effective communication between all local parties involved in the study to align common goals and define best strategies: Be the main link to the local monitoring team in the management of studies. Collaborate with Vendor Functional Line Managers (FLM) to drive quality and study KPIs, plan / participate in study site engagement activities (i.e. Recruitment Booster calls), work closely and proactively with MDAs / SELs early on to drive the country strategy, coordinate local study team meeting, establish collaboration with GBU Medical Affairs regarding trial conduct and medico-marketing activities.
  5. Maintain Quality and Compliance: Responsible for data quality, patients' safety and maintain compliance to study metrics for his / her country(ies). Ensure appropriate quality for data collection and queries resolution. Ensure CRA Study Training according to Study Training metrics through FLMs, collaborate with QL on audit and inspection related activities, ensure PAI readiness within CTMS, TMF and other systems.

About You:

  1. Bachelor's degree in nursing, biochemistry or related natural science.
  2. Experience in clinical research is mandatory, preferably in combination with experience in project management and certain time as field monitor or site-coordinator.
  3. Solid knowledge of clinical development process and relevant therapeutic / disease area(s).
  4. Strong skills in Project Management, problem-solving and risk-management skills in a clinical study environment.
  5. Data analytic skills and use of digital tools, platforms and systems.
  6. Interpersonal skills with ability to create and foster trustful relationships with several internal and external stakeholders.
  7. 10% travel (in-country travel).

PLAY TO WIN BEHAVIORS:

  1. Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won't; be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment.
  2. Put the interest of the organization ahead of own of those of his / her team: consider both short- and long-term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level.
  3. Act in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings an external perspective into decisions.
  4. Take action and don't wait to be told what to do: take smart and informed best bets with the information at hand and anticipate the consequences of her / his actions; use personal judgement and others' advice to make bold and impactful decisions which move us forward.
  5. Pursue progress, discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at Sanofi. IS AN EQUAL OPPORTUNITY EMPLOYER.

If you are interested in applying for this vacancy and you are confident that you meet the criteria set out in the advertisement kindly click on the link below. Apply Here

#J-18808-Ljbffr

  • Country Clinical Study Manager

    7 days ago

    Pretoria, Gauteng, South Africa Clinical Research Training Academy Full time

    About UsClinical Research Training Academy (CRTA) is a global organization dedicated to advancing the field of clinical research.We are seeking an experienced Country Clinical Study Manager to join our team. As a key member of our operations team, you will be responsible for managing clinical studies in your assigned countries and ensuring the timely...

  • Study Operations Lead

    7 days ago

    Pretoria, Gauteng, South Africa Clinical Research Training Academy Full time

    About UsClinical Research Training Academy (CRTA) is a global organization dedicated to advancing the field of clinical research.We are seeking an experienced Study Operations Lead to join our team. As a key member of our operations team, you will be responsible for leading study operations in your assigned countries and ensuring the timely execution of...

  • Clinical Research Site Leader

    7 days ago

    Pretoria, Gauteng, South Africa Clinical Research Training Academy Full time

    Job DescriptionClinical Research Training Academy (CRTA) is seeking an experienced Clinical Research Site Leader to join our team. As a key member of our operations team, you will be responsible for leading clinical research sites and ensuring the successful execution of clinical trials.Main Responsibilities Include:Develop and implement site-level...

  • Global Trial Operations Director

    7 days ago

    Pretoria, Gauteng, South Africa Clinical Research Training Academy Full time

    About UsClinical Research Training Academy (CRTA) is a global organization dedicated to advancing the field of clinical research.We are seeking an experienced Global Trial Operations Director to join our team. As a key member of our operations team, you will be responsible for directing global trial operations and ensuring the timely execution of clinical...

  • Study Operations Specialist

    3 hours ago

    Pretoria, Gauteng, South Africa Findojobs South Africa Full time

    Job Summary:We are seeking a Study Operations Specialist to join our research team at Findojobs South Africa.As a Study Operations Specialist, you will be responsible for ensuring the smooth operation of clinical trials, from planning and coordination to execution and monitoring.Your primary responsibilities will include developing and implementing study...

  • Clinical Trials and Studies Manager

    7 days ago

    Pretoria, Gauteng, South Africa Aj Personnel Full time

    Job Description:Aj Personnel is seeking a highly skilled Medical Officer to join our research team. The successful candidate will have experience in research coordination, project management, and clinical trials.About the Role:This is an exciting opportunity for a motivated and detail-oriented individual to take on a key role in managing clinical trials and...

  • Clinical Research Manager

    2 weeks ago

    Pretoria, Gauteng, South Africa Msd Full time

    Job DescriptionThis 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, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the CRM could be...

  • Country Medical Director

    7 days ago

    Pretoria, Gauteng, South Africa Smith Garb Full time

    Job Description: Medical Advisor - Vaccines StrategySmith Garb is seeking a highly experienced Medical Advisor to join our team. As a Medical Advisor for Vaccines Strategy, you will play a key role in shaping the future of vaccine access and uptake in South Africa.In this strategic position, you will develop and execute a comprehensive Vaccines Country...

  • Study Site Coordinator Lead

    11 hours ago

    Pretoria, Gauteng, South Africa E2E Staffing (PTY) LTD Full time

    About E2E Staffing (PTY) LTD:">We provide personalized staffing solutions tailored to the specific needs of our clients in the healthcare sector.Our objective is to empower our clients with exceptional talent, driving their success in a dynamic environment.">About the Position:">We seek an accomplished Contracts Administration Specialist to join our team....

  • Trial Data Management Professional, Clinical Studies

    7 days ago

    Pretoria, Gauteng, South Africa Parexel International Full time

    Parexel International is looking for an experienced FSP Clinical Data Programming Expert to join our team in South Africa. As a key member of our team, you will contribute to the development of software systems and infrastructure to support clinical studies.About the PositionYou will be responsible for creating data review listings, exception reports,...

  • Clinical Trial Coordinator

    2 weeks ago

    Pretoria, Gauteng, South Africa Iqvia Argentina Full time

    ASSIGNMENT PROFILEClinical Trial Coordinator (CTC)Description of Roles and ResponsibilitiesTrial and site administration: Tracking (e.g., essential documents) and reporting (e.g., Safety Reports). Ensure collation and distribution of study tools and documents. Update clinical trial databases (CTMS) and trackers. Clinical supply & non-clinical supply...

  • Clinical Operations Manager Sa

    2 days ago

    Pretoria, Gauteng, South Africa Ananzi Full time

    Company Overview:Ananzi is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development and technology solutions across more than 20 therapeutic areas.Our team conducts...

  • Clinical Research Manager

    2 weeks ago

    Pretoria, Gauteng, South Africa Merck Full time

    Job DescriptionThis 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, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the CRM could be...

  • Junior Study Coordinator

    6 days ago

    Pretoria, Gauteng, South Africa E2E Staffing (PTY) LTD Full time

    Junior Study Coordinator Position:We are seeking a highly motivated and detail-oriented Junior Study Coordinator to join our team at E2E Staffing (PTY) LTD. As a Junior Study Coordinator, you will assist the Principal Investigator and study team in the day-to-day running of research sites.Main Responsibilities:Develop and maintain knowledge of Good Clinical...

  • Clinical Research Operations Specialist

    1 week ago

    Pretoria, Gauteng, South Africa Aecom Full time

    We are passionate about developing our people through career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards programs. As a Clinical Research Operations Specialist, you will be responsible for managing projects, leading teams, and ensuring compliance with regulations.Job...

  • Clinical Research Manager

    2 weeks ago

    Pretoria, Gauteng, South Africa Merck Gruppe - Msd Sharp & Dohme Full time

    Job DescriptionThis 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, our company's policies and procedures, quality standards, and adverse event reporting requirements internally and externally. For certain studies, the CRM could be...

  • Global Clinical Operations Specialist

    1 week ago

    Pretoria, Gauteng, South Africa Ananzi Full time

    Job Overview:Fortrea is a global leader in contract research organizations, providing innovative solutions for clinical development and technology across various therapeutic areas. We have over 18,000 staff conducting operations in more than 90 countries, transforming drug and device development for partners and patients worldwide.We are currently seeking an...

  • Clinical Trial Manager Ii

    14 hours ago

    Pretoria, Gauteng, South Africa Syneos Health, Inc. Full time

    Updated : December 19, Location : South Africa-Europe - ZAF-Home-Based Job ID : Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings...

  • Study Coordinator III

    1 week ago

    Pretoria, Gauteng, South Africa Parexel Full time

    About ParexelParexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today's top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients. You'll be an influential member...

  • Senior Study Coordinator

    7 days ago

    Pretoria, Gauteng, South Africa Syneos Health, Inc. Full time

    Job SummaryThis role oversees interdisciplinary clinical research studies as a project manager, ensuring compliance with GCP, SOPs, and regulatory requirements.You will act as the primary liaison between Syneos Health and the Customer, ensuring timely study launch, conduct, and closeout according to contractual agreements.The successful candidate will lead...