Job details
Job type full-time
Full job description
Job description
Full time regular with benefits
Remote in the u.s/canada
Summarized purpose:
Acts as a senior data management specialist for one or more local laboratory data projectsLeads all data management activities associated with local labs for individual studies and serves as a cross-functional liaisonMay support more complex projects.
Essential functions
Collaborates on the design and user acceptance testing of local lab ecrfs and ensures proper set up of specific lab tool.
Ensures data entry and review are performed and consistent with requirements defined by procedure and data validation manual.reviews lab related documentationand listing review tools for compliance with study protocol and lab standards.
Liaises with colleagues in other functional groups, and provides support to senior team members by providing training to clinical staff on local lab procedures, attending project and client team meetings when required, and working with medical monitors to ensure robust review of local lab and related data.
Provides training and work direction to junior team members.
Ensures study specific lab normal range mailbox is effectively managed by junior level staff.
Reviews all lab documentation within data validation manual, electronic edit checks, and ecrf completion guidelines.
Job qualification
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 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.
This is a great opportunity for experienced ascp medical technologist due to the nature of understanding local reference laboratory data.
Knowledge, skills and abilities:
Solid understanding of challenges of local lab data used in clinical trials to include -collection of local lab ranges, relationship between local lab results and units, relationship between local lab results, ranges and potential adverse events, relationship between local lab data and ctcae or other grading tools
Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
Favorable interpersonal skills with an internal and external customer focus
Capable of mentoring junior level staff
Proven flexibility and adaptability when working in a team and independently using good judgment in making decisions
Good computer skills and knowledge of databases and how to effectively extract and interpret data
Strong written and verbal communication skills
Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data
Demonstrated ability to analyze processes and contribute to process improvement initiatives
Familiarity with the broader clinical trial process
Working environment:
Ppd values the health and wellbeing of our employeesWe support and encourage individuals to create a healthy and balanced environment where they can thriveBelow 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.
Ability 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.
Ppd defining principles:
- we have a strong will to win - we earn our customer’s trust - we are gamechangers - we do the right thing - we are one ppd
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
Tags: local lab team, mt(ascp), senior medical technologist,
Diversity statement
Ppd is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respectPpd is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
