- Prepares, reviews and coordinates, under mentorship and local EC submissions in alignment with global submission strategy.
- Supports preparation, of local MoH submissions, as applicable.
- Review with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines;
ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieves PPD's target cycle times for site.
- May have contact with investigators for submission related activities.
- May act as a key-contact at country level for either Ethical or Regulatory submission-related activities.
- Works with the start-up CRA(s)
to prepare the regulatory compliance review packages, as applicable.
- Assists in developing country specific Patient Information Sheet / Informed Consent form documents.
- Assists with grant budgets(s) and payment schedules negotiations with sites.
- Enters and maintains trial status information relating to SIA activities onto PPD, or client (where contracted) supervising databases in an accurate and timely manner
- Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
- Maintains knowledge of and understand PPD SOPs, Client SOPs / directives, and current regulatory guidelines as applicable to services provided.
Job Complexity
Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily acquired.
Education and Experience :
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills,
and abilities to perform the job (comparable to 0 to 3 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities :
- Effective oral and written communication skills
- Clinical Trial Management System (CTMS)
- Attention to detail and quality of documentation
- Negotiation skills
- Good digital literacy and the ability to learn appropriate software
- English language and grammar skills fluently
- Basic medical / therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction
- Planning skills
- Knowledge of all applicable regional / national country regulatory guidelines and EC regulations
No management responsibility
Working Conditions : Remote
- Access and use a variety of computer software developed both in-house and off-the-shelf.
- Communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with team members to acquire or relate information to diverse groups.
