Senior Manager, Site Engagement Lead - Western Canada

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

BA/BS/BSc or RN required; advanced degrees preferred (M.D., D.O., PhD, PharmD, Master's)., Experience in life sciences or clinical research, particularly in biopharmaceuticals or CROs., Strong understanding of clinical trial processes, ICH-GCP, and local regulations., Ability to travel up to 30% for site engagement activities..

Key responsibilities:

  • Lead operational site engagement and establish partnerships with key sites for clinical trial execution.
  • Drive strategic relationships and provide local intelligence to enhance Amgen's engagement strategy.
  • Monitor site operational strategies and performance across therapeutic areas in collaboration with Amgen partners.
  • Communicate regularly with key sites to resolve issues and improve their experience with Amgen.

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AMGEN Biotech: Biology + Technology Large http://www.amgen.com
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Job description

Career Category
Clinical
Job Description
Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Role: Senior Manager, Site Engagement Lead – Western Canada

Reports to: Senior Manager, Development Operations

Location: Western Canada Based Remote Worker

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for the areas below.

Accountabilities
  • 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 partners, ensuring aligned and collaborative approach to site’s experience with Amgen interactions.
Responsibilities

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(ies);
  • Proactive and accountable to drive expansion of Amgen’s strategic relationships and meet clinical operational needs as subject matter expert;
  • 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 partners;
  • 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 partners (medical, study management, site management, and other key -stakeholders) to drive operational efficiencies;
  • Strong collaboration with regional and/or country Study Managers to ensure clear roles and responsibilities. Communicate cross-study lessons learned, and maintain working relationships with sites;
  • Share information and cross-study metrics to Key Stakeholders, e.g. 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 resolve 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.
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
What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.

Basic Qualifications:

  • BA/BS/BSc or RN
  • 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)
  • Country clinical operations experience and/or regional study management experience
  • Ability to travel (Up to 30%)

Preferred Qualifications:

  • M.D., D.O., PhD, PharmD, Master’s Degree
  • Expertise and in-depth understanding of site engagement with clinical trials, or building and/or coordinating community research network
  • 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 results, 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)
What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The salary range for this role in Canada is $145,000 - 165,000 CAD

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.
careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Required profile

Experience

Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Problem Solving
  • Collaboration
  • Communication
  • Leadership

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