Trial Manager, Project Data Management Services (PDMS)

Job Description

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock. Works with with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality. Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements. Manages change, customer and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents Global Data Management on cross-functional trial teams and in other trial-level development forums.

Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs. Participates in the development of, and ensures adherence to, our Company's clinical data management procedures. Interacts with staff across our Company's multiple sites.

Primary Activities:

• 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.
• 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 social, 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 necessary for a trial.
• Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.
• Facilitates assessment and processing of standards and change requests.
• Approves trial-level data validation plan (including project and protocol specific data validation elements).
• 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 necessary to achieve database lock (or data extraction) are completed by appropriate functional area.
• Ensures timely archival of trial data and documentation.
• Ensures timely decomissioning of clinical data management technologies. ​​​
• Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned
• Supports site and sponsor audits, as appropriate
• Identifies and supports improvements to data collection and data management processes and tools.

Education:

• B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.

Prerequisites:

• At least 3 years’ in Clinical Data Management with at least 1 year working with formal project management tools and processes.

Knowledge and Skills:

• Knowledge of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle.
• Familiar and comfortable with database concepts and tools to manage, extract, and report data.
• Strong organization and management skills.
• Must be able to communicate effectively — 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” that great medicines can make a significant impact to our world. 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.

Who we are ...

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.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]
For more information about personal rights under Equal Employment Opportunity, visit:

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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R73413