Associate Director, US Study Start-Up

GSK

1d•$129,750 - $216,250•Hybrid

About The Position

The Associate Director, Study Start-up is responsible for providing leadership in the execution of operational strategy and management of start-up activities for all clinical trials, across all therapy areas. This includes, but it’s not limited to the overall management and oversight of the following processes: preparation and submission of CTA for EC and CA, site contracts and TPRM for core and CRO-managed countries. The role is the accountable person for the study start up metrics (these metrics can be shared with other directors/manager depending on local leadership roles, where appropriate). This position works directly with Clinical Operations Head, LDL Managers, SEL/LDL, STEP team, CRO FSP (Functional Service Provider) Managers and/or BDL where appropriate, in setting priorities and expectations for Study Start-Up. The role is supporting the life cycle of the studies and improve processes across functions. This position may manage Study Start Up Leads (SSUL), Clinical Operations Specialists (COS) and other functions involved in study start up activities, depending on countries.

Requirements

University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.
5+ years of experience in clinical operations or similar positions in the pharmaceutical industry.
Solid knowledge of ICH-GCP, local regulations, and regulatory processes.
Experience managing study start-up activities across multiple sites in the US.

Nice To Haves

Advanced degree such as Master’s, PharmD, or PhD
Demonstrated leadership skills and experience working in matrix teams.
Experience in budget control and monitoring of performance indicators.
Analytical skills and a results-oriented mindset, with a focus on operational efficiency and quality.
Proven track record of reducing study start-up timelines or improving activation metrics.
Strong stakeholder engagement, negotiation and influencing skills.
Experience leading cross-functional projects or process improvement initiatives.

Responsibilities

Accountable to ensure timely start-up of all clinical studies across multiple therapeutic areas to agreed start up timelines according to set metrics, budget and quality target working according to country/regional (where appropriate) regulations, GSK SOPs and ICH GCP.
Support operations between the central GSK study team, global SSU team and within-country study team for study start up activities.
Ensures that critical study timelines related to study start up activities within-country are accurately forecasted.
Accountable for maintaining internal tracking for study site status from initial site contact through site initiation. Maintains clear internal team communication and documentation to ensure site activation timelines are met.
Accountable for the delivery of country feasibility, site selection, recruitment planning, site training and/or regulatory package completion.
Actively works with stakeholders to simplify/optimize processes as it relates to their area of expertise. Responsible for identifying and sharing best practices.
Connects with local internal and external experts to keep up to date with changes in site start-up requirements. Learns from past site activations and performance and continually improves future activities.
Consulted for the LOC CRO’s oversight (operational aspects) when studies are delivered through the FSO (Fully Study Outsourced) Model.
Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.
Represent GSK in key events (i.e Forum, Symposium, Trade Association, etc) and discussion related to the improvement of clinical research activities in the national environment.
Accountable to lead Study Start Up Leads and/or Local Clinical Operations Specialists to ensure timely start-up, operational management, completion and delivery of all clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality target working according to country/regional regulations, GSK SOPs and GCP.
Accountable for line and performance management of Team Members: conduct regular 1:1 meeting, develop staff competencies and identify skill gaps. Arranges appropriate training to ensure they have the skills and knowledge required. Utilizes coaching and mentoring strategy to enhance individual and overall team performance.
Responsible for resource management and allocation to maintain business performance and a sustainable workload.