Start Up Lead

Precision for Medicine

6d•$91,500 - $137,300

About The Position

The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for executing the site start-up strategy and plan. The role manages and coordinates core and site document collection and approval, informed consent form (ICF) customization and approval, IRB/EC and CA/MoH submissions, and delivery of quality IMP release packages. The SU Lead serves as a subject matter expert for in-country colleagues supporting site start-up, trains less-experienced staff, and may own country-specific tools and guidance documents to share knowledge of local start-up activities. The role develops activation-readiness strategies and critical-path plans, coordinates stakeholders and client communications, oversees tracking and progress metrics, identifies and mitigates delivery risks, and coordinates document translations. The SU Lead works with functions including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts, and may directly support country- or site-level start-up work. The position also supports country start-up summaries and training, mentors staff on local regulations and procedures, and contributes to proposal activities and client presentations. Occasional travel may be required. The position requires a bachelor's degree in life sciences or a related field, or an RN or equivalent combination of education, training, and experience; at least five years of start-up experience; and at least two years of project milestone management, resource management, and team coordination experience. Advanced life-sciences education is preferred. Candidates must be legally authorized to work in the country of employment without employer sponsorship. The estimated compensation range is $91,500–$137,300 USD. The role is eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Requirements

Bachelor's degree in life sciences or a related field, Registered Nurse (RN), or an equivalent combination of education, training, and experience.
At least 5 years of start-up experience, ideally with SU Lead or project management experience in a CRO or pharmaceutical/biotechnology industry, or equivalent relevant experience and/or demonstrated competencies.
At least 2 years of experience in project milestone management, resource management, and coordinating team activities.
Demonstrated leadership experience driving cross-functional activities.
Excellent communication and organizational skills.
Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
Fluency in English and, for positions based in non-English-speaking countries, the local language.
Experience using milestone tracking tools or systems.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Ability to follow task-specific procedures, attend to detail, and prioritize accuracy of information.
Ability to interact effectively with project teams and communicate in English and the local language of the country where based.
Ability to work independently in a fast-paced environment with a sense of urgency.
Excellent computer skills.
Excellent time-management and prioritization skills to meet deadlines.
Excellent written and spoken communication, presentation, and interpersonal skills, including the ability to inform, influence, convince, and persuade.
Legally authorized to work in the country of employment without employer sponsorship.

Nice To Haves

Advanced degree in life sciences or a related field.
SU Lead or project management experience in a CRO or pharmaceutical/biotechnology industry.
Occasional travel may be required.

Responsibilities

Manage site start-up through development of an activation-readiness strategy that enables oversight of site start-up delivery.
Coordinate, develop, and present critical-path planning, including IRB/EC and CA/MoH strategy, ICF customization, risk mitigation, IMP release requirements, and contract execution.
Collaborate and communicate with stakeholders to secure input for milestone planning and align operational goals to support timely site activation.
Participate in client meetings to establish expectations for delivery, communication, risk mitigation, status reporting, and site start-up metrics.
Partner with functional leaders and Site Start-up Specialists to identify delivery risks and develop and execute mitigations to protect timelines.
Oversee the accuracy, completeness, and real-time maintenance of agreed tracking and systems so progress can be analyzed against study-, country-, and site-level targets and timelines.
Coordinate translations of documents required for submissions.
Communicate project status and deliverables with Feasibility, Clinical Operations, Project Management, Regulatory, Site Contracts, and other functions involved in country start-up.
Serve as a subject matter expert on site-level critical-path-to-IMP-release data, including local IRB/EC timelines, other reviews required for activation, site contracts and budget negotiation requirements, and other country start-up requirements.
Directly support country- or site-level start-up activities when needed.
Support development of country-specific start-up summaries and process flows identifying timelines, risks, and success factors.
Support development and facilitation of training sessions, respond to questions as a subject matter expert, and mentor staff on local study start-up regulations, submissions, internal procedures, and SSDL.
Participate in proposal activities, including developing slides and presenting to clients as required.
Perform other duties as assigned by management.