Clinical Trial Site Engagement Sr Manager

2 semanas atrás


Sao Paulo, Brasil Amgen Tempo inteiro

Clinical Trial Site Engagement Sr Manager

Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets. Maintains an effective collaborative partnership with all stakeholders, ensuring aligned and synergistic approach to site’s experience with Amgen interactions.

Leadership of Operational Site Engagement
- Align and lead identification and strategic partnership with key sites to implement a collaborative initiative for clinical trial execution.
- Accountable for strategic long-term operational partnerships with key sites, provide local intelligence, and contribute to maintaining a consistent and coherent voice as part of Amgen’s overarching engagement strategy. Collaborate with other cross functional roles for ‘tailored’ global execution of study(is).
- Primary site-facing, cross-study, operational decision-maker between Amgen and designated key sites for the purposes of establishing Amgen-Institutional operational working practices.
- Maintain country expertise, site knowledge to navigate with Amgen and sites with targeted and tailored communication.
- Develop, drive and monitor site operational strategies and performance across all therapeutic areas and studies, in strong collaboration with Amgen stakeholders.
- Assimilate and report external feedback to evaluate and propose operational process efficiencies, focus and direction for site collaboration on clinical trials.
- Orchestrate relationship management and strong internal alignment with Amgen stakeholders (medical, study management, site management, and other key -stakeholders) to drive operational efficiencies.
- Strong collaboration with Regional and/or Local Trial Manager (RCTM/LTM*) to ensure clear roles and responsibilities. Communicate cross-study lessons learned and maintain consistent working relationships with sites.
- Share information and cross-study KPIs to Key Stakeholders, e.g., DOM, DFM, CTOM, Study Managers etc.

Locally accountable for key, targeted sites execution of clinical studies
- Build and develop strong relationships with key sites to engage with Amgen as Choice for clinical trial participation, to effectively advance site operational engagement and better understand current site processes to enhance our clinical trial execution.
- Regular communication with key sites to connect on all trials/all stages to determine trends and opportunities and enhance site’s experience with Amgen. On-site visits as appropriate (per site and situation).
- Maintaining quick and direct access to key sites’ leadership & operation teams, point of escalation for operational, cross-study potential barriers and operational issues.
- Internal point of contact to navigate working with key sites, and to help key sites navigate working with Amgen.
- Centralize and socialize site intelligence technology, such as working practices, operational documents, to enhance clinical trial efficiencies at site.
- Participation in cross-functional task forces / process improvement groups.

GSO quality management
- Actively participates in role forums including local and global functional and cross functional initiatives.
- Participates in Functional Management Team (FMT) Meetings as required and applicable country-level project review meetings.

**Minimum Requirements**

**Basic Qualifications**
- Minimum 6 years’ experience in clinical research in a role that oversees (project/clinical operations management)
- Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
- Availability for travel (~60% of the time)
- Fluent English

**Preferred Qualifications**
- M.D., D.O., PhD, PharmD, Master’s Degree
- Country clinical operations experience and/or regional study management experience
- Expertise and in-depth understanding of site engagement with clinical trials, or building and/or coordinating community research networks

**Skills & Knowledge**
- In depth understanding of drug development process, clinical trial conduct, ICH-GCP and local regulations, requirements, and guidelines
- Project and Program management including oversight of quality, study deliverables, budgets and timelines
- Various therapeutic area knowledge
- Fluency in written and spoken English
- Clinical trial management systems and reporting tools
- Utilization of Key Performance Indicators (KPIs)

**Competencies**
- Commitment to uphold ethics and the Amgen values
- Ability to work independently as well as in a team/matrix environment on multiple projects and countries
- Analytical and problem solving skills
- Decision making
- Oral and written communication skills
- Strategic operatio



  • Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    **Clinical Project Manager** **(Level Depends on Experience)** **Job Purpose/Summary**: Responsible for management and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client’s goals of time, budget and quality performance are met. The Clinical Project Manager I is expected to require support and guidance from Directors and/or...


  • Sao Paulo, Brasil IQVIA Tempo inteiro

    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...


  • Sao Paulo, Brasil Novasyte Tempo inteiro

    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...

  • Clinical Trial Manager

    Encontrado em: Talent BR C2 - Há 6 dias


    São Paulo, Brasil IQVIA Tempo inteiro

    Clinical Trial Manager The Clinical Trial Manager provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in...


  • Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix. Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s). Ensures allocated tasks are performed on time, within budget and...

  • Clinical Trial Management Associate Manager

    Encontrado em: Talent BR C2 - 2 semanas atrás


    São Paulo, Brasil BeiGene Tempo inteiro

    BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR...

  • CMM - Clinical Medical Manager (Talent Pipeline)

    Encontrado em: Talent BR C2 - 2 semanas atrás


    São Paulo, Brasil Novo Nordisk AS Tempo inteiro

    Step into the Future: Join Novo Nordisk's Talent Pipeline! Are you ready to shape the future of healthcare with Novo Nordisk? We are thrilled to announce an opportunity within our Talent Pipeline, where we actively seek top-tier professionals to join our pioneering team in the first semester of 2024. The Talent Pipeline provides an exceptional...

  • Clinical Trial Administrator II

    Encontrado em: Talent BR C2 - 1 semana atrás


    São Paulo, Brasil PSI CRO Tempo inteiro

    Job DescriptionJoin our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. Only CVs in English will be accepted.You will be responsible for:Customization of Site ICF/patient documents before sending it to sites;EC- IRB submissions;Site Room, Veeva...

  • Clinical Trial Administrator II.

    Encontrado em: Talent BR C2 - 1 semana atrás


    São Paulo, Brasil PSI Tempo inteiro

    Job Description Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.  Only CVs in English will be accepted. You will be responsible for: Customization of Site ICF/patient documents before sending it to sites; EC- IRB submissions; ...


  • Sao Paulo, Brasil IQVIA Tempo inteiro

    Job Overview Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general...


  • Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    It's more than just something that fills our days. At Thermo Fisher Scientific, our work has a purpose. Our work requires passion and creates meaningful outcomes. Our work matters. We're sharing our expertise and technological advancements with customers, helping them make the world a better place - whether they're discovering a cure for cancer, protecting...

  • Clinical Trial Coordinator

    Encontrado em: Talent BR C2 - 2 semanas atrás


    São Paulo, Brasil Fortrea Tempo inteiro

    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 Operations Manager

    Encontrado em: Talent BR C2 - 2 semanas atrás


    São Paulo, Brasil Fortrea Tempo inteiro

    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...

  • Clin Trials Assistant

    Encontrado em: Talent BR C2 - 2 semanas atrás


    São Paulo, Brasil Fortrea Tempo inteiro

    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 Trial Coordinator

    Encontrado em: Talent BR C2 - 2 semanas atrás


    São Paulo, Brasil Fortrea Tempo inteiro

    Requirements: Completed job training (finance), or Bachelor’s Degree 1-2 years of experience in Finance of clinical trials (focused on site payments); Advanced English Advanced Excel Hands-on Attention to details Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the...

  • Cra Line Manager Sr

    Há 6 dias


    Sao Paulo, Brasil Novo Nordisk Tempo inteiro

    CRA Line Manager Sr. **Category**:Clinical Development**Location**:São Paulo, São Paulo, BR- Seize the opportunity to shape your career with Novo Nordisk! We're on the lookout for a dynamic Clinical Research Associate (CRA) Line Manager Sr. to lead our expanding Clinical Trials division. In this pivotal role, you will take charge of a team of internal and...

  • CMM - Clinical Medical Manager (Talent Pipeline)

    Encontrado em: Talent BR C2 - 2 semanas atrás


    São Paulo, Brasil Novo Nordisk Tempo inteiro

    The job location is São Paulo, SP. Your responsabilities includes: Identify and map KOLs, investigators, and research centers within relevant therapy areas, collaborating closely with clinical operations teams across regions during feasibility and allocation processes. Engage with patient advocacy groups, exploring mutual interests and potential...

  • CMM - Clinical Medical Manager (Talent Pipeline)

    Encontrado em: Whatjobs BR C2 - 2 semanas atrás


    São Paulo, Brasil Novo Nordisk Tempo inteiro

    The job location is São Paulo, SP. Your responsabilities includes: Identify and map KOLs, investigators, and research centers within relevant therapy areas, collaborating closely with clinical operations teams across regions during feasibility and allocation processes. Engage with patient advocacy groups, exploring mutual interests and potential...

  • Clinical Team Lead

    Encontrado em: Talent BR C2 - 2 semanas atrás


    São Paulo, Brasil Fortrea Tempo inteiro

    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...

  • Engagement Manager

    Há 3 dias


    Sao Paulo, Brasil Hatch Tempo inteiro

    **Requisition ID**:90747 **Job Category**:Consulting **Location**:Sao Paulo, Sao Paulo, Brazil Join a company that is passionately committed to the pursuit of a better world through positive change. With more than 65 years of business and technical expertise in mining, energy, and infrastructure, our 10,000 colleagues in 150 countries tirelessly work...