Associate Start up Lead

• Manage the site start up process through development of an activation readiness strategy to enable

• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy (if

• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment

• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation

• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to

• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained

• 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

• Act as SME for collection and maintenance of site level critical path to IMP Release data points such

• 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

• Support development and facilitation of training sessions to expand Country Start-up knowledge and

• 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

• Performs other duties as assigned by management.

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

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

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

• 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

• Fluency in English and for non-English speaking countries the local language of country where position

• Experience using milestone tracking tools/systems.

• Advanced degree in life sciences or related field

• 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

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

• 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

• Occasional travel may be required

Originally posted on Himalayas