Trial Data Coordinator:CLI006390
Description
MSD is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, biologic therapies, and consumer care and animal health products. Today, we are building a new kind of healthcare company : one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Associate Trial Manager assists in ensuring the successful execution of the clinical trial data management strategy for assigned trials within a specific drug/vaccine program. Assists in start:up activities, database maintenance, and database finalization for each trial. Attends Study Team meetings and works in a team environment. Assists in developing and managing project plans which span from protocol development through database lock. Ensures all aspects of the project plan are executed on time and with appropriate quality.
Primary Activities
Under the guidance/supervision of more senior staff assumes the following responsibilities:
1: Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug/vaccine program. Data includes, but is not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes.
2: Supports the project management of all clinical data management activities with incremental responsibilities for trials as assigned, using excellent interpersonal, negotiation, and project management skills to assist with the following tasks:
: Project planning, initiation, execution, change control, and closing.
: Risk management identification.
: Meeting customer/stakeholder expectations.
3: Meets trial:level requirements for quality data collection and validation at the trial level.
: Reads and interprets the clinical protocol from a clinical data management perspective.
: Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.
: Ensures appropriate use of standards and project:level consistency of database design, data collection, and validation.
: Facilitates assessment and assists in processing of standards and change requests.
4: Participates and manages trial:level data quality and completion of database lock and post:database lock activities:
: Monitors overall status and quality of data being collected during the in:life portion of a trial.
: Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.
: Ensures timely archival of trial data and documentation.
: Ensures timely decommissioning of clinical data management technologies.
Qualifications
Education: B.A. or B.S. degree, preferably in life science, or related discipline.
Experience: At least 2+ years experience in data management, medical research, or database design and development additional experience in project management tools and process would be beneficial.
Knowledge and Skills: Good basic awareness of the clinical research development process. Familiar with database concepts and tools. Proven leadership skills, specifically the ability to coordinate the work of others. Good sense and awareness of regulations and policies. Must be able to communicate effectively : orally and in written form : with other stakeholders
Our employees are the key to our companys success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. MSDs benefits are designed to support the wide range of
goals, needs and lifestyles of our employees,
Salario:Competitive
Ciudad: vicente lóp
Salario:Competitive
Ciudad: vicente lópez
