Senior Consultant Clinical Trial Strategy
|Job Title||Senior Consultant (Clinical Trial Strategy)|
Credevo is a global consulting organization supporting healthcare product development from clinical development to commercialization. Credevo provides strategic support in areas such as regulatory, clinical development, licensing (out-/in-), and feasibility support, for products including pharmaceuticals, biologics, nutraceuticals, and medical devices.
We are seeking a highly motivated and detail-oriented individual to join our team as a Senior Consultant (Clinical Trial Strategy). In this role, you will be responsible for providing strategic support and coordination for the successful planning and execution of clinical trials.
This position is open to candidates from India, the Philippines, Thailand, Malaysia, Sri Lanka, and Indonesia.
Essential duties and responsibilities (including, but not limited to the following):
The incumbent should be able to perform the following activities while working remotely:
- Communication and coordination with customers to understand their needs for clinical trials.
- Evaluation of product details, business needs, and customer requirements to
- identify the study rationale,
- identify key geographic regions for the trial,
- prepare a strategic plan for the trial and
- advise on the way forward.
- Provide on-hand support in the identification, selection, and management of key internal and external teams for various activities in the clinical trial.
- Collaborate with relevant team members to develop and implement study protocols, standard operating procedures (SOPs), and informed consent documents.
- Assist in the selection and evaluation of investigational sites, investigators, and vendors, ensuring their compliance with study requirements.
- Achieve study objectives and timelines by coordinating with relevant teams for the preparation and submission of applications for regulatory and ethics committee approvals
- Collection, maintenance, and review of study documents, including case report forms (CRFs), source documentation, and regulatory files.
- Effective clinical operations, viz. monitoring and tracking study progress, including enrollment status, adverse events, and protocol deviations
- The timely and accurate completion of data entry and data management activities, including data cleaning, query resolution, and database lock
- Ensuring timely reporting to the management team and relevant stakeholders
- Maintain comprehensive and up-to-date knowledge of relevant regulations, guidelines, and best practices in clinical research.
- Contribute to the development and improvement of study processes, SOPs, and quality control measures.
- Education: At least a Masters’s degree in medicine, pharmacy, or a scientific- or healthcare-related field.
- Prior Work Experience: At least 5 years of experience in clinical trials, preferably focusing on clinical trial strategy, plan, and design.
- Job Knowledge:
- Strong understanding of Good Clinical Practice (GCP) guidelines, industry standards, and regulatory requirements, particularly in regions of Southeast Asia, East Asia, Japan, and Australia
- Strong understanding of drug development process and clinical trial methodology & operations.
- Excellent attention to detail and the ability to prioritize and multitask in a fast-paced environment.
- Strong written and verbal communication skills, with the ability to effectively collaborate with internal and external stakeholders.
- Demonstrable problem-solving skills and ability to exercise independent judgment.
- Proficiency in using clinical trial management systems and electronic data capture (EDC) systems.
- Advanced level expertise in using Excel and Word.
- On-hands past experience of conducting studies in South East Asia, East Asia, Japan, and Australia (desirable).
- Certification in clinical research/project management (such as ACRP or SoCRA or PMP) (desirable).
- Language Proficiency: Expert written communication skills in the English language – This should be demonstrated by prior work and during the selection process. Good English speaking skills with the ability to understand different international accents are also required.
IMPORTANT: You will need to login to your gmail / google account for authentication to apply.