Job Application for Associate Start up Lead at Precision Medicine Group

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Precision for Medicine is looking for an Associate Start Up Lead to join our team. The position could be covered fully remotely from Serbia, Romania, Hungary, Slovakia or Poland.

Position Summary:

The Associate Start Up Lead is experienced in driving country and/or regional site start-up activities and

is accountable for the execution of the site start-up strategy and planning, including the management and

coordination activities such as Core/Site document collection and approval, ICF customization and

approval, IRB/EC and delivery of quality IMP release packages. The Associate Start Up Lead may also

have global exposure to CA/ MoH submissions. Will act as Subject Matter Expert for questions by other

in-country members (RSSs, CRAs, PSSs or others) supporting site start-up activities, may support

development of country specific tools and guidance documents to increase knowledge share of country

specific site start-up activities.

Essential functions of the job include but are not limited to:

• 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 (if

assigned to global study), 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.

• May 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.

Minimum Required:

• Bachelor's degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination

of education, training, and experience.

• 3 years or more in start-up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/

biotech industry.

• 1 year or more experience in project milestone management, managing resources, budgets and

coordinating team activities.

• 1 year or more experience presenting to clients.

Other Required:

• 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

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.

• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of

information.

• Excellent organizational skills.

• Ability to effectively interact with project team(s) and effectively communicate in English and the local

language of the country where located.

• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.

• Must demonstrate excellent computer skills.

• Excellent time management and prioritization skills to ensure deadlines are met.

• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to

inform, influence, convince, and persuade.

• Occasional travel may be required.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, private medical insurance, MultiSport Card, life insurance, pension, home working allowance, vacation, among other benefits.

Reasonable estimate of the current range for Poland:

142,900 PLN - 214,300 PLN gross per annum

#LI-NC1

#LI-Remote

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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Associate Start up Lead

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