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.
RESPONSIBILITIES:
- Develops career plans for direct reports aligned to GDMS organization's goals and provides developmental opportunities through the following methods:
- Identifies challenging growth assignments.
- Coaches for performance attainment in addition to communicates timely frequent feedback to support growth.
- Performs periodic skill assessments evaluations as well as leads annual performance appraisals.
- Shares rewards and recognition where appropriate
- Facilitates team priority setting in addition to individual priority setting.
- Ensures direct reports receive appropriate training and mentoring.
- Develops promotion strategies and prepares promotion recommendations.
- Possesses innovative mindset focused on continuous improvement and operational efficiency within team in addition to cross-functionally.
- Displays collaborative approach in problem solving, governance, change management and appropriately synthesizes key business information to management where appropriate.
- Identifies, facilitates, and directs work assignments aligned to resource availability and constraints.
- Maximizes staff effectiveness by working with direct reports to ensure a realistic workload that supports value-added work and work-life balance, estimating length and difficulty of tasks and projects, anticipating, and adjusting for obstacles and setbacks, and elevating complex issues to the appropriate management level.
- Participates in the recruitment, interview, candidate selection process in addition to performance improvement plan/termination as necessary.
- Assumes specific functional leadership responsibilities for business deliverables assigned to direct reports or supervised staff on project.
- Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts.
- May serve as a functional area head with responsibilities for determining Standard Operating Procedures and other business practices for that area (including management of an operating budget)
- Determines, collects, and interprets performance metrics. Identifies correction strategies and ensures they are implemented accordingly. Manage performance. Conducts management and functional area meetings, contributing expertise, when necessary, through formal or informal presentations
- Stays current in technology and regulatory changes both within and outside of our companies that may impact staff. May participate in or lead initiatives beyond GDMS (e.g. cross-divisional projects, cross-industry initiatives, etc.) May support any other project or perform any other data management or drug surveillance task deemed appropriate by management.
- May supervise contingent, non-exempt, or temporary workers, onshore and offshore.
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Education:
- At least B.A. or B.S. degree in relevant discipline.
Knowledge and Skills:
- Minimum 6 years' experience in Clinical Data Management or Pharmacovigilance as appropriate to business role or related industry experience preferred, at least 3 years of supervisory or management experience
- Strong knowledge of Clinical Development through submission Process, ICH, GCP guidelines and CFR 21 regulations related to Clinical Development and Technologies. Must understand the technology landscape of the Clinical Development and integrations of the different solutions.
- Knowledge of database structures and available tools to manage, extract, and report data, general Technology aptitude.
- Ability to find innovative and sustainable solutions to people, process, technology, and organizational issues.
- Ability to adapt to constantly changing environment and to be able to contribute to the change as well.
- Ability to work collaboratively with other functional areas, divisions, and vendors.
- Ability to synthesize information from multiple sources, provide cohesive response, identify optimal path forward and communicate to management in clear, and concise manner and any actionable items.
- Strong organizational, time management, problem solving and project coordination skills.
- Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas.
- Strong sense of urgency and leadership abilities.
- Ability to present in a group environment.
- Ability to lead a team.
- Ability to be flexible, multi-task and work independently.
- Basic knowledge of statistical concepts.
#EligibleforERP
ResearchandDevelopmentGCTO
#ONEGDMS
NOTICEFORINTERNALAPPLICANTS
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.
Current Employees apply HERE
Current Contingent Workers apply HERE
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. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$135,500.00 - $213,400.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
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
Search Firm Representatives Please Read Carefully
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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
No
Job Posting End Date:
11/25/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R319286