Merck Data Management Trial Manager in West Point, Pennsylvania
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
Oversees the data management strategy and project plans for collection and integration of all clinical data including but not limited to, case report forms (CRF) data, lab data, biomarker data, and patient reported outcomes for one or more trials within a specific drug program. Works with a cross-functional team across multiple sites to ensure that all aspects of the project plan (from protocol planning through data management submission components) are executed on time and with appropriate quality. Serves as project manager of all clinical data management activities for trials as assigned.
Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:
Project planning, initiation, execution, change control, and closing.
Project team development, project team leadership, meeting management, and resource coordination.
Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.
Management of customer / stakeholder expectations; facilitation of cross-functional decisions.
Defines 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.
Engages with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial. Ensures appropriate use of standards and project-level consistency of database design, data collection, andvalidation.
Facilitates assessment and processing of standards and change requests.
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.
Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.
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 timelydecommissioningof clinical data management technologies.
Position Qualifications :
Education Minimum Requirement:
B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Required Experience and Skills :
At least 3 years' of Clinical Data Management Experience;
Full life-cycle experience in clinical data management (data collection system development through database lock and close-out and submissions;
At least 1 year experience working with formal project management tools (MS Project) and processes.
Preferred Experience and Skills:
Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle.
Familiar and comfortable with database concepts and tools tomanage, extract, and report clinical data.
Strong organization and management skills.
Must be able to communicate effectively both orally and in written form with technical and business areas.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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Requisition ID: R6587
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