Precision Medicine Group ยท 1 week ago
Start Up Lead
United States
Full-time
Remote
Senior Level
$92K/yr - $137K/yr
5+ years expPrecision Medicine Group is a leading organization in the field of precision medicine, seeking a Start Up Lead to manage global site start-up activities. The role involves executing site start-up strategies, coordinating critical planning, and collaborating with stakeholders to ensure timely delivery of site activities.
BiotechnologyHealth Care
Responsibilities
Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery
Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution
Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation
Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up
Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines
Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels
Responsible to co-ordinate translations for documents required for submissions
Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables
Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country
If needed, directly support country or site level activities start up activities
Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors
Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries
Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL
Interact with clients in proposal activities, including slide development and client presentation as required
Performs other duties as assigned by management
Qualification
Required
Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience
5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies
2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities
Demonstrated leadership experience in driving cross-functional activities
Excellent communication and organizational skills are essential
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
Fluency in English and for non-English speaking countries the local language of country where position based
Experience using milestone tracking tools/systems
Preferred
Advanced degree in life sciences or related field
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase