Local Study Associate Director- FSP

About the role

The Local Study Associate Director (LSAD) leads Local Study Teams (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

Responsibilities

• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction).
• Plays a key role in patient recruitment strategy including regular communication with participating Investigators as necessary.
• Develops, maintains and reviews risk management plans on country study level; proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Plans and leads National Investigator meetings, in line with local codes, as required.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management Document.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and client Procedural Documents.
• Plans and leads activities associated with audits and regulatory inspections in liaison with Clinical Quality Associate Director (CQAD) and QA.
• Provides input to process development and improvement.
• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
• Updates Line Managers about the performance of the CRAs/CSAs.
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Supports local Medical Affairs team.
• Completes timesheets accurately as required.
• Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.

Requirements

• Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Excellent project management skills.
• Excellent team building and interpersonal skills.
• Excellent organizational skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent attention to detail.
• Proficient in written and spoken English language required.
• Fluency in local language(s) required.
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.

Skills (Essential)

• Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Excellent project management skills.
• Excellent team building and interpersonal skills.
• Excellent organizational skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent attention to detail.
• Proficient in written and spoken English language required.
• Fluency in local language(s) required.
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.

Skills (Desirable)

• Good analytical skills.
• Good resource management skills.
• Good decision making and delegation skills.
• Good financial management skills.
• Basic change management skills.
• Basic coaching skills.
• Basic ability in handling crisis situations.

Knowledge And Experience (Essential)

• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
• Good knowledge of international guidelines ICH GCP as well as relevant local regulations.

Knowledge And Experience (Desirable)

• Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
• Good knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including monitoring.
• Very good understanding of the Study Drug Handling Process and the Data Management Process.
• Good intercultural awareness.

Education

Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.