Associate Director, Clinical Data Management,...

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.

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.

Will be able to work independently or as a team member or leader with equal effectiveness.

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.

Primary activities include, but are not limited to:

• 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

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

• Associates Degree with at least 7 years’ professional experience in clinical data management -OR-

• High School Diploma (or equivalent) with at least 10 years’ professional experience in clinical data management

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

#MSJR

#eligibleforERP

#Clinicaltrialjob, Audit Readiness, Clinical Data Management, Communication, Cross-Functional Leadership, Data Standards, GxPs, Inspection Readiness, Mentor Coaching, Process Improvements, Project Management, Regulatory Experience, Risk Management

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

The salary range for this role is

$142,400.00 - $224,100.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.