Senior Clinical Data Manager - Argentina - Remote
Location: Buenos Aires, Argentina
Requisition Number: 3312
Position Title: Senior Clinical Data Manager
Data Management is an ever growing and collaborative department! Our global team is a group of diverse individuals with wide-ranging experience within the industry. From start to finish, we are involved in clinical studies beginning with building the study database, to locking and delivering the final dataset for the project. Data Management reviews and ensures the clinical study data is of high quality for regulatory submissions.
The Data Management group is the perfect place to launch or further your career. Whether it is technical expertise, or coming from a clinical background, you’re able to hone and expand your skillset within our department. Spanning various roles from data support staff, database and SAS programmers, coders and functional leads, there is place for you!
The Senior Clinical Data Manager will provide leadership, management, and technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate and timely manner to the Sponsor’s satisfaction.
This role is full time, permanent and can be homebased in Argentina.
Tasks may include but are not limited to:
- To manage each of the data management projects to which assigned; provide leadership to the corresponding data management teams.
- To represent WCT in all dealings with Sponsors with respect to the Data Management aspects of the projects to which assigned.
- To liaise with the Director, Data Management at regular intervals to discuss progress and any issues outstanding.
- To take responsibility for staff training for all projects to which assigned; both direct involvement in training and supervision of staff assigned to training.
- To liaise and collaborate with corresponding teams in other WCT departments working on the same project.
- To ensure that all data management operations are conducted to WCT SOPs; contribute to the ongoing revision/improvement of these SOPs.
- To create and review project specific documentation for assigned trials, i.e. the Data Management Plan and the Data Management File.
- To write specifications for the set-up and modification of database and edit check specifications for assigned projects.
- To write and validate Manual and SAS checks.
- To set-up processes for reconciliation and perform reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory).
- To perform verification and User Acceptance Testing of configured databases.
- To support and oversee all data cleaning activities for assigned projects.
- To specify and review SAS listings/SAS tables for assigned projects.
- To create and review CRF and eCRF completion guidelines, EDC system manuals and access instructions.
- To train others to make full and correct use of the company Data Capture systems, when used, for the collection of clinical data.
- To produce information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendor.
- To liaise with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees (CEC) within clearly defined guidelines for matters concerning processing of data.
- To ensure that adequate QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects.
- To ensure timely database locks for all assigned projects.
- To participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings. Ensure that any recommendations are discussed and that solutions are incorporated.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
OTHER SKILLS AND ABILITIES:
- The job holder must be computer literate and numerate with a willingness to adapt to various computer systems.
- It is essential that the job holder works with close attention to detail and is questioning about the validity of the data being entered and has an ability to phrase data queries in an understandable and impartial manner.
- To have the ability to train new staff and to monitor their performance.
- Proven project delivery skills.
- Several years experience within Data Management or associated field.
- Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience Promotion to the next level is not automatic based on years of experience.
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
Employment Type: Regular
Community / Marketing Title: Senior Clinical Data Manager - Argentina - Remote
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.