Senior/ Site Activation Specialist

IQVIA; Petaling Jaya; On-site; MYR 60,000 - 90,000; Full time

Job summary

IQVIA is looking for a candidate based in Petaling Jaya, Selangor, Malaysia, to serve as a Single Point of Contact for clinical studies. The responsibilities include performing regulatory, start-up, and maintenance activities, as well as negotiating site contracts and ensuring adherence to project timelines. Ideal candidates hold a Bachelor's degree in life sciences with at least 3 years of clinical research experience, and possess strong communication and negotiation skills. This role requires in-depth knowledge of clinical systems and regulatory guidelines.

Qualifications

• Bachelor’s degree in life sciences or related field; 3 years of relevant experience.
• In-depth knowledge of clinical systems and corporate standards.
• Good communication and organizational skills.

Responsibilities

• Serve as Single Point of Contact in assigned studies.
• Perform regulatory, start‑up and maintenance activities.
• Review, prepare and negotiate site contracts and budgets.

Skills

Clinical research expertise

Negotiation skills

Attention to detail

Interpersonal skills

Knowledge of GCP/ICH guidelines

Education

Bachelor's degree in life sciences

Job description

Job Responsibilities

• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.
• Perform regulatory, start‑up and maintenance activities according to applicable regulations, SOPs and work instructions.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Review, prepare and negotiate site contracts and budgets with sites, if applicable.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project‑specific information.
• Ensure contracts are fully executed, regulatory documents and approvals are granted, IP release authorized and specific project deliverables are completed.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement a contingency plan as needed.
• May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and the wider company, as required.
• May assist in pre‑award activities including bid defenses, proposals and oversight of the scope of work at country level.
• May provide input into contract and budget template development.
• May support importation activities.
• May have direct contact with sponsors on specific initiatives.
• May act as a local regulatory, ethics and contract expert and reviewer of ICF.
• May act as mentor, and prepare and deliver country‑specific training for less experienced staff.
• May participate in feasibility and/or site identification activities.
• May perform site selection visits if a trained monitor.

Job Requirements

• Bachelor’s degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or an equivalent combination of education, training and experience.
• In‑depth knowledge of clinical systems, procedures and corporate standards.
• Good negotiating and communication skills with the ability to challenge, if applicable.
• Effective communication, organizational and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and the company’s corporate standards.
• Understanding of the regulated clinical trial environment and knowledge of the drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.