Imbria Pharmaceuticals’ mission is to translate our understanding of cellular metabolism into innovative medicines that improve the lives of patients with limited or inadequate treatment options. The company was founded by doctors and launched by an all doctor executive team motivated by the promise of bringing new therapies to people in need.
We are propelled by a deep scientific interest in cellular metabolism and the mitochondria, and are guided by both values and a code of business conduct built upon our commitment to always put the patients, families and communities we serve at the forefront of all that we do. More information can be found at www.imbria.com.
Global Clinical Trial Manager is responsible for leading a cross-functional study team and for providing the team with direction and clear decisions to enable successful delivery of clinical studies from receiving study specifications through to study archiving.
- Lead a cross-functional team of experts to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality in line with ICH/GCP and relevant SOPs
- As Clinical Study Manager you are the point of contact to the CRO to ensure delivery to time, quality and cost; ensuring that appropriate sponsor oversight of the CRO is defined and performed across relevant sponsor functions for outsourced studies.
- Develop and maintain up to date study plans (e.g. global study management plan, monitoring plan, etc.) lead study level performance against agreed upon plans, and lead proactive risk and contingency planning and raise issues to stakeholders as appropriate
- Provide input and hold accountability for the development of essential study level documents (i.e. Clinical study Protocol)
- Responsible for leading the selection of vendors, handling their performance to ensure high quality, timely delivered services
- Ensure appropriate training is provided to investigators and site staff as well as vendor teams as needed
- Responsible for study budget throughout the study, providing budget progress reports to management
- Ensure studies are inspection-ready at all times, according to ICH-GCP, SOP and relevant policies/guidelines
- Responsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspection
- You may be assigned responsibility for leadership or participation in non-drug project work including applying process improvements methods and change management techniques
- Anticipate problems and propose risk mitigation plans to ensure successful and timely completion of the trials
- Actively and effectively communicate within Clinical Operations across functional and geographic areas regarding the developments, progress, activities and results for assigned responsibilities.
- Participation in RFP’s and in the selection of CRO’s and other applicable vendors.
Minimum Education, Experience, Knowledge and Skills Required:
- A minimum of BA/BS Degree
- At least 7 years of relevant clinical experience in the pharmaceutical industry, or a similar organization (e.g. CRO) including clinical trial leadership experience (preferable on global trials)
- Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development
- Possess strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing
- Proven understanding of and recent experience with clinical study budget management
- Good communication and relationship building skills, including vendor management skills
- Travel required (moderate 25%)
Imbria offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to firstname.lastname@example.org.