𝗚𝗹𝗼𝗯𝗮𝗹 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 M𝗮𝗻𝗮𝗴𝗲𝗿.

𝗝𝗼𝗯 𝗗𝗲𝘀𝗰𝗿𝗶𝗽𝘁𝗶𝗼𝗻:
Global Business Development Executive (BDE)/Manager will be responsible for identifying and cultivating new opportunities within the clinical research industry, conducting market research, building client relationships, and generating leads through strategic business development initiatives.

𝗝𝗼𝗯 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀:

• Promote sales of the company’s clinical research solutions.
• Develop and implement effective business development strategies.
• Responsible for business expansion by identifying new opportunities and target markets.
• Identify potential clients, establish long-term relationships, and nurture partnerships to drive sustained business growth.
  Work closely with cross-functional teams to develop customized solutions that meet specific client needs.
  Stay informed on industry trends and competitor offerings, identifying new opportunities to position us as a preferred contract research partner.
  Deliver on sales and revenue goals to contribute to overall business growth.
  
  

𝗝𝗼𝗯 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀:

• Life Sciences Graduate with an MBA
• 1–5 years of experience in business development or sales in a CRO
• Strong communicator, able to work independently and collaborate across teams
• Skilled in negotiation, problem-solving, and business analysis
• Excellent interpersonal and time management abilities; thrives under pressure
• Proactive, detail-oriented, with strong writing and presentation skills

Interested candidates are invited to submit their resume and cover letter, via email to our HR department at [email protected] .

Clinical Study Start-up and Regulatory Assistant Manager/Manager

Position Summary

The Clinical Study Start-up and Regulatory Manager is responsible for leading and managing the regulatory and site activation process for clinical trials. This role ensures that clinical study sites are initiated efficiently and in compliance with regulatory requirements, Good Clinical Practice (GCP), and study protocols. The manager works closely with sponsors, ethics committees, regulatory authorities, and study teams to facilitate timely study start-up and regulatory submission

Key Responsibilities

Study Start-up & Site Activation

• Oversee and manage all aspects of study start-up, including regulatory submissions, ethics committee approvals, and site activation.
• Develop and implement start-up strategies to accelerate site initiation and first patient enrollment.
• Ensure timely preparation, submission, and tracking of essential documents, including clinical trial agreements, investigator site files, and informed consent forms.
• Collaborate with clinical operations, investigators, and site teams to address start-up challenges and regulatory requirements.
• Coordinate with legal teams for contract negotiations and budget approvals with study sites.

Regulatory Compliance & Submissions

• Prepare, review, and submit regulatory documentation in compliance with country-specific and global regulatory requirements (FDA, EMA, ICH-GCP, etc.).
• Maintain up-to-date knowledge of regulatory guidelines, policies, and emerging trends in clinical research.
• Act as the primary liaison between sponsors, regulatory agencies, and ethics committees.
• Ensure timely response to queries and requests from regulatory bodies and ethics committees.
• Develop and maintain regulatory intelligence databases and trackers to monitor submission timelines.

Stakeholder & Site Management

• Build strong relationships with investigators, site personnel, and regulatory authorities.
• Train and support clinical research teams on regulatory requirements and study start-up processes.
• Lead meetings with internal and external stakeholders to provide updates on site activation progress.
• Ensure clear communication and resolution of regulatory issues that may impact study timelines.

Process Improvement & Quality Assurance

• Identify opportunities to optimize and streamline the study start-up process.
• Implement best practices and process improvements for regulatory compliance and site activation efficiency.
• Ensure the completeness and accuracy of trial master file (TMF) documentation related to start-up activities.
• Conduct internal audits and quality checks to ensure adherence to regulatory and sponsor requirements.

Key Skills & Competencies

• Regulatory Expertise: In-depth knowledge of clinical trial regulations, ICH-GCP guidelines, and ethics committee processes.
• Project Management: Strong ability to manage multiple studies, prioritize tasks, and meet deadlines.
• Attention to Detail: Ensures accuracy and compliance in all regulatory submissions and site activation processes.
• Communication & Negotiation: Strong verbal and written communication skills to engage with regulatory bodies, ethics committees, and internal teams.
• Problem-Solving: Ability to proactively identify and resolve regulatory and site activation challenges.
• Stakeholder Management: Builds and maintains strong relationships with sponsors, investigators, and regulatory authorities.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
• Minimum 5+ years of experience in regulatory affairs, clinical trial start-up, or site activation.