Associate Director, Clinical Data Management

MSD Malaysia; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck, a global health care leader, seeks a Principal Trial Manager in Rahway, NJ to lead data management initiatives and ensure compliant execution across trials. You will mentor SMEs, drive end-to-end data management knowledge, and guide process improvements within GDMS.

Responsibilities include cross-functional collaboration, training, and leading complex risk management while upholding regulatory standards and audit readiness.

Qualifications

• Bachelor's degree in life sciences, computer science, or related discipline.
• At least 6 years of experience in Clinical Data Management or a mix between Data Management and Clinical Research.
• At least 3 years' experience with formal project management tools and processes.

Responsibilities

• Lead Special Projects and Initiatives within GDMS.
• Act as a SME, mentor, and trainer on data management, project management, leadership and other areas of expertise.
• Support Training & Development programs to promote Trial Manager end-to-end proficiency.
• Support and provide input to functional process owners to support process implementation.
• Partner with functional area representatives to ensure consistent use of database standards and trial design support.

Skills

Clinical Data Management

Project Management Leadership

Mentoring Staff

Cross-Functional Initiative

Communication Skills

Problem-Solving

Leadership

Study Life Cycle

Education

BA/BS in life sciences, computer science, or related discipline

Tools

Formal PM tools

Job description

The Principal Trial Manager is responsible for leading projects and initiatives to improve the quality and compliance of the data management functional areas in addition to the regular responsibilities as an individual Trial Manager. The Principal Trial Manager is responsible and accountable for the successful execution of the clinical data management strategy for one or more drug or vaccine trials within the TM role. Will be responsible for leading and/or representing data management functional areas or GDMS in cross-functional initiatives and project teams as deemed appropriate. Principle Trial Managers will possess end-to-end data management knowledge with strong project management and leadership skills which are transferable from pipeline to process to special initiatives. Will interact with Trial Managers as SME, Mentor and Trainer within areas of expertise and provide project leadership to help develop knowledge within the department and will be able to work independently or as a team member or leader with equal effectiveness.

Primary Activities

• Lead Special Projects and Initiatives within GDMS.
• Act as a SME, mentor, and trainer on data management, project management, leadership and other areas of expertise.
• Support Training & Development programs to promote Trial Manager end-to-end proficiency.
• Support and provide input to the functional process owners (PO)/ potentially serving as an SME to support process implementation.
• Partner with functional area representatives to assess and promote consistency in the use of database standards and trial design/peer review support as needed.
• Identifies, defines and implements improvements to data collection, data and project management processes and tools.
• Support audits and inspections as necessary.
• Functional & cross-functional special project management.
• Complex Risk Management.
• All required activities outlined in the TM job description.

Education and Experience

• B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline,
• at least 6 years' experience in Clinical Data Management or a mix between Data Management and Clinical Research and
• at least 3 years' experience working with formal project management tools and processes.

Knowledge and Skills

• Demonstrated accomplishments through all phases of the Study Life Cycle.
• Proficient overall working knowledge on the clinical development process.
• Knowledge of applicable regulations and policies.
• Be able to work under pressure in a changing environment with flexibility.
• Ability to work independently and accept and act with appropriate accountability with minimal guidance by management.
• Ability to coordinate the work of others and drive decision making.
• Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
• Exceptional demonstrated organizational, problem-solving and negotiating skills.
• Demonstrated excellent project management and leadership skills.
• Demonstrated ability to coach and mentor others.
• Demonstrated ability to lead a cross functional Initiative with broad impact to Quality and Compliance.

Required Skills

• Ability to Coordinate
• Clinical Data Management
• Clinical Data Standards
• Data Management
• Detail-Oriented
• Good Clinical Practice (GCP)
• Influencing Skills
• Mentoring Staff
• Project Management Leadership
• Strategic Thinking

Preferred Skills

• Cross-Functional Teamwork
• Decision Making
• Deliverables Management
• Leadership
• Leading Project Teams

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.