Summarized Purpose :
Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer.
Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time / quality / cost expectations.
Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.
Typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities.
Essential Functions :
e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies.
Responsible for the timely archiving of documents and study materials for the department.
Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits(AFVs) and be accountable for project financials.
Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees.
Responsibilities may vary based on project timelines.
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 8+ 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 :
Working Environment :
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment / requirements for this role :
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
This role requires independent travel up to 20%, inclusive of traveling in automobiles, airplanes, and trains.