Clinical Data Management - Program Manager

Job Description

Job Description

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.

The Program Manager oversees the successful execution of the clinical data management strategy for one or more drug or vaccine programs. Accountable for ensuring Global Data Management regulatory submission deliverables are available for all in-scope trials. Ensures all aspects of the project plan (from protocol planning through data management submission components) are executed on time and with appropriate quality; coordinates and aligns deliverables of Trial Managers working at trial level within assigned programs. Acts as the single point of contact and represents Global Data Management on cross-functional program teams and in other program-level development forums.

Provides direction for integrating external teams into the data management processes and ensures that data from disparate sources and database structures align with the clinical data management strategy. Participates in the development of, and ensures adherence to, company clinical and regulatory data management standards.

Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple sites. Mentors, guides, and provides project leadership for junior staff as assigned.

Primary Responsibilities:

Oversees the data management strategy and project plans for collection and integration of all clinical data (including, but not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes) for one or more drug or vaccine development programs. Works with other groups to coordinate these deliverables. Partners with functional area representatives to ensure appropriate use of database standards and program-level consistency on database, data collection, review, and retrieval specifications. Serves as project manager of all clinical data management activities for trials and/or programs as assigned. Monitors the Book of Business and program-specific clinical development plan(s) to initiate data management resourcing and activities at the appropriate time. Provides program-related oversight and guidance to Trial Managers, and ensures quality and consistency of data management requirements and deliverables, through archival, across trials within a program. Uses excellent interpersonal, negotiating, and project management skills to perform the following tasks:

• Project plan development, execution, and change control
• Project team development, resource planning, and cost estimating
• Risk management (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control), including engagement with leads and managers for issue resolution and escalation as necessary
• Communications planning, information distribution, performance reporting, and project closure
• In-licensing due-diligence assessment
• Management of customer / stakeholder expectations; facilitation of cross-functional decisions.
• Keeps abreast of project and clinical data management disciplines through interaction with experts both within and outside of the company.
• Identifies and develops improvements to data collection and data management processes and tools.
• Supports audits and inspections as necessary.
• May lead a continuous improvement special project, or any other data management task deemed appropriate by management.
• May serve as Trial Manager for one or more trials within assigned programs.

Education:

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

Experience:

• At least 6 years’ experience in Clinical Data Management with at least 3 years’ experience working with formal project management tools and processes.
• Knowledge of the clinical development process, preferably through submission; thorough knowledge of clinical data management; demonstrated leadership and project management skills; strong organization, communication, and problem-solving skills.
• Experience with managing outsourced and/or licensing arrangements preferred.

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:R76999