Principal Clinical System Lead

hace 2 semanas


Bogota, Colombia ICON A tiempo completo

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

We have an incredible opportunity for a **Principal Clinical System Lead** to join ICON’s Full Service Clinical Data Science team.

**LOCATION**:

- Mexico (Office-Based with remote flexibility)
- Colombia (Home-Based)
- Canada (Home-Based)
- United States (Home-Based)

**OVERVIEW OF THE ROLE**:
The Principal Clinical System Lead will lead and direct one or more Clinical Data Science (CDS) project teams engaged in the initiation, planning, set up, maintenance, control, and closing of systems used in clinical trial projects.
- Support sales efforts by participating in and providing expertise to Business Development and assist with and present at Bid Defense meetings
- Perform peer review of study team technical documentation and work output
- Act as a contact point for internal and external customer teams on assigned studies
- Lead project kick off (internal and external) meetings
- Perform quality control peer review of CRFs
- Track and keep functional management and those responsible for project management informed of any issues that might affect project target dates, scope, or budget and escalate potential problems
- Work independently and with other project leads, as needed, to negotiate timelines and key deliverables with clients and/or external customers and departments
- Contribute to the oversight and management of system integration set up and vendor interactions where needed
- Understand project level revenue recognition/forecasting process and provides input regarding actual and forecasts units/hrs (revenue and resources) to the CDS PM
- Lead and guide multiple technical teams of programmers, designers, and data validation analysts to achieve common project goals
- May independently supervise, including direct line management, a limited number of junior level individuals and deputise in place of the functional manager
- Travel (approximately 15 %) domestic and/or international

**TO BE SUCCESSFUL, YOU WILL NEED**:

- 8+ years of clinical data management experience including implementation and management of clinical data systems
- Technical understanding of relational databases and how they function and be able to create medium to complex data flow diagrams
- Applied skills in project management, including the predictive elements of timelines, resource requirements, and financial tracking
- Detailed understanding of protocol content and interpretation of data collection requirements, both considering user experience and underlying dataset structures
- Ability to react quickly and adapt to changing requirements, processes, and timelines in an agile manner
- Ability to lead teams in the internal UAT of configured System solutions
- Excellent written and verbal communication skills
- Bachelor’s degree or local equivalent
- _ Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write, and speak fluent English and host country language._

**BENEFITS OF WORKING IN ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.

In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

**ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.**

LI-TCT1



  • Bogota, Colombia ICON A tiempo completo

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


  • Bogota, Colombia ICON plc A tiempo completo

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

  • Clinical Data Lead

    hace 3 semanas


    Bogota, Colombia ICON plc A tiempo completo

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


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: The Principal Medical Writer Safety Lead is responsible for development and management of medical writing deliverables, with a focus on safety reporting, such as participant narratives, that support the clinical regulatory writing portfolio.Capable of working independently to achieve goals.In this role the Principal Medical Writer Safety...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: The Principal Medical Writer Safety Lead is responsible for development and management of medical writing deliverables, with a focus on safety reporting, such as participant narratives, that support the clinical regulatory writing portfolio.Capable of working independently to achieve goals.In this role the Principal Medical Writer Safety...

  • Clinical Operations Lead

    hace 3 semanas


    Bogota, Colombia Amgen A tiempo completo

    **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...

  • Clinical Data Manager

    hace 3 semanas


    Bogota, Colombia MSD A tiempo completo

    **Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. **Position Overview**: Under the direction of the...

  • Senior Clinical Data Lead

    hace 4 semanas


    Bogota, Colombia ICON plc A tiempo completo

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


  • Bogota, Colombia ICON plc A tiempo completo

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

  • Clinical Data Manager

    hace 3 semanas


    Bogota, Colombia MSD A tiempo completo

    **Job Description**: **Position Overview**: Under the direction of the applicable management, the Clinical Data Manager is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review...


  • Bogota, Colombia AlignTech A tiempo completo

    **Join a team that is changing millions of lives.** Transforming smiles. Transforming lives. Transforming an industry. At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever is next. We revolutionized the orthodontic industry with the introduction of the...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. **Position Overview**: Under the direction of the...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: - Position Overview:_ - Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity review and...


  • Bogota, Colombia MSD A tiempo completo

    Activities may include, but are not limited to: _ - Creates and develops clinical databases and data transfer files according to written specifications. - Leads and participates in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. **Position Overview**: Under the direction of the...


  • Bogota, Colombia AlignTech A tiempo completo

    **Join a team that is changing millions of lives.** Transforming smiles, changing lives At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have...

  • Field Clinical Specialist

    hace 3 semanas


    Bogota, Colombia Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Territory**:Colombia**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important...


  • Bogota, Colombia ICON plc A tiempo completo

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


  • Bogota, Colombia Merck Sharp & Dohme A tiempo completo

    This role primarily supports in bigger regions (LATAM, Central America and Caribbean) the study portfolio management, focusing in development and strengthening of the regional capabilities in clinical research in assigned Therapeutic Areas (TA). Under the supervision and oversight of the Regional Operations Head, this role supports the the study allocation...

  • Drug Safety Lead

    hace 1 mes


    Bogota, Colombia Organon A tiempo completo

    **The Position** - Leads signal detection, safety evaluation and risk management planning and activities for low-medium complex_, _medicinal products and/or medical devices during clinical development and/or for established brands from a scientific perspective by active participation and contribution to, amongst others, the Organon Asset teams (when...