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Precision For Medicine · 1 day ago

Associate Start Up Lead

United States

Full-time

Remote

Mid Level

$69K/yr - $103K/yr

3+ years exp

Precision Medicine Group is a leading organization in the clinical research and pharmaceutical industry, seeking an Associate Start Up Lead. The role involves managing site start-up activities, coordinating with stakeholders, and ensuring the execution of site start-up strategies to enable timely activation of sites.

BiotechnologyHealth CareMedicalMedical DevicePharmaceutical

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 (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

Qualification

Site start-up managementProject milestone managementRegulatory submissionsMilestone tracking toolsFluency in EnglishLeadership experienceComputer skillsCommunicationOrganizational skillsTime management

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 or equivalent, relevant experience and/or demonstrated competencies

1 year or more experience in project milestone management, managing resources, budgets and coordinating team activities

1 year or more experience presenting to clients

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 For Medicine

Precision for Medicine is a specialized scientific services company helping life science innovators develop medical products. It is a sub-organization of Precision Medicine Group.

Founded in 2012

Frederick, Maryland, USA

1001-5000 employees