Study Start-Up Leader

2+ years

Not Disclosed

Bangalore

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Study Start-Up Leader
Company: [Insert Company Name]
Location: [Insert Location]

About This Role:
The Study Start-Up Leader is responsible for executing the study start-up strategy and overseeing the planning and management of activities related to study initiation. This includes aligning with country regulations, document collection/approval, ICF customization/approval, EC and RA/MoH submissions, SIV scheduling, and activation requirements. The role involves coordinating and leading critical path planning, system setup, and risk mitigation strategies to ensure the timely activation of sites.

Key Accountabilities:

Manage the overall study start-up process, ensuring the development and execution of a site activation strategy and governance.
Oversee the coordination of activities including critical path planning, site initiation scheduling, system setup, and regulatory strategy (EC & RA/MoH submissions).
Collaborate with the global study team to provide start-up strategy input, contribute to milestone development, and align operational targets for timely delivery of study start-up activities.
Participate in client meetings to discuss study start-up, endorse operational targets, mitigate delivery risks, and establish client expectations for communication, reporting, and metrics.
Work closely with Functional Leaders and Local Site Managers to proactively identify and resolve study start-up issues.
Develop corrective actions to address any risks related to activation timelines.
Ensure systems are maintained and updated to monitor study start-up progress against targets and timelines at the project, country, and site level.
Deliver client-focused reporting to track performance, identify issues, and propose resolutions.

Skills & Qualifications:

Knowledge of international regulatory requirements and guidelines (i.e., ICH-GCP, EU-Directives).
Strong critical thinking, problem-solving, and conflict management skills.
Ability to think strategically and tactically, with excellent risk management and contingency planning abilities.
Experience in leading virtual teams across multiple cultures and locations.
Strong interpersonal, communication, presentation, and consulting skills.
Client-focused, action-oriented, and able to influence both vertically and horizontally within the organization.
Exceptional organizational skills, with the ability to manage multiple tasks and prioritize effectively.
Self-driven with the ability to manage assignments independently and from a distance.
Strong attention to detail and a sense of urgency in task completion.
Proficient in MS Office applications (Outlook, Word, Excel) and capable of using various systems to track study progress.

Knowledge & Experience:

Proven experience in client-facing roles within healthcare, clinical research, project management, or CRO environments.
Experience working in multi-national organizations and managing global projects.
Prior project management experience is preferred.
Expertise in end-to-end study start-up activities, particularly in a leadership capacity.
Competence in written and oral English communication.

Education:

A degree in life sciences or relevant clinical trial experience, especially in study start-up activities.
An advanced degree is preferred.

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Study Start-Up Leader

Job Description

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