Study Start Up Specialist
Department: Integrative Sciences
Employment Type: Full Time
Reference Number: 2067041
- Manage the study start up process, through development of a site activation strategy and to oversee delivery of efficient start up milestones
- Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, Risk Mitigations, Monitoring Plan, Site Activation Requirements & Relevant Tools.
- Collaborate and communicate within the study team matrix to provide study start up strategy, input to milestone development, and alignment of operational targets to ensure timely delivery of study start up activities.
- Participate in meetings with respect to study start up
- Partner closely with Clinical Operations and CRO
- Proactively identify study start up related issues
- Develop and execute corrective actions to mitigate risks to activation timelines
- Ensure that relevant systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level).
- Deliver and maintain reporting to measure performance and proactively identify issues for resolution
What is Required
- Bachelors' Degree in a life science or relevant clinical trial discipline
- 4+ years' experience within a Clinical Research, Site Activation, or Study Start Up unit at a CRO, Biotech or Pharma
- Knowledge of applicable FDA and international regulatory requirements and guidelines
- Critical thinking and problem solving
- Strategic & tactical thinking skills
- Conflict management skills
- Ability to work with virtual teams across cultures and locations
- Excellent interpersonal, verbal, written and presentation skills
- Strong Leadership skills, with ability to influence both vertically and horizontally
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Able to work independently and manage assignments from a distance
- Sense of urgency and organization in completing tasks
- Strong understanding of cultural differences
- Proficient computer and internet skills, including working knowledge of MS-office applications, such as MS Outlook, Word and Excel
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies