Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.
Conduct in-house data review
Generate and close queries or apply self evident corrections to the data according to the relevant guidelines
Identify and report protocol violations
Manual and Patient Profile review, issue queries
Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action
Track and integrate queries
Perform clinical coding if appropriate to role within the project team
Ensure all documents coded for submission to central files
Lock site(s) within EDC system - remove user's data modification privileges
Interact with site (via mail) as required
Perform early and final database QC activities
Update all relevant tracking system on an ongoing basis
Inform responsible CDA coordinator of work status regularly
Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor
Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and stud specific procedure
Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims
Excellent interpersonal, verbal and written communication skills
Excellent computer skills including but not limited to the knowledge of Clinical Trial / Data Management Systems, PMED, IVRS, MS-Office products such as Excel, Word.
Sound awareness of all relevant regulations, including GCP
Posses a thorough understanding of the various tasks related to project initiation, ongoing monitoring / processing and lock
Carefully weighs the priority of project tasks and directs team accordingly
Understands the strengths and development areas of team members
Ability to lead a 'virtual', global team as required
Gives others appropriate latitude to make decisions
Looks for win-win solutions to solve problems
Ability to make appropriate decisions in ambiguous situations
Ability to solve problems by using a logical, systematic, sequential approach
Communicate and work effectively with clients
Enlists the support of team members in meetings goals
Proposes new approaches, methods or technologies
Anticipates how others will react to situations
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work
Plans and delivers verbal and written communications that persuade the intended audience
Willing and able to travel as required ' local or international
Why Work at PAREXEL
There are pivotal moments in every career : Sharing new treatments. Improving processes. Delivering life-saving advances.
The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path?
A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That’s Parexel. We’re a diverse team of professionals focused on one goal : getting treatments into the hands of those who need them most.
Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.