Lead Clinical Data Manager (m/f/d)

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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

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

Due to team expansion, we are currently looking for an experiencedLead Clinical Data Manager (LCDM)to be based in our new office in Zürich.

Position Overview:

Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with the Standard Operating Procedures (SOPs) and ICH-GCP guidelines. Works with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload and resource allocation. Supports the comprehensive development of junior staff and encourages effective interaction with business partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of deliverables at the trial level.

Primary activities include, but are not limited to:

• All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager (CDM).
• Responsible for all protocol level start-up, in-life and database lock tasks and activities.
• Interact and communicate with customers and stakeholders both internal and external to GDMS when needed.
• Responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data Management Plans (DMPs).
• Coordinate &/or participate in the execution of user acceptance testing of data management tools.
• Provide inputs into the preparation of the investigator meetings materials and makes him/her available for questions. May present data management instruction at investigator meetings based on business need and management decision.
• Participate in relevant operational meetings to identify and incorporate global operational issues into the study design.
• Execute and trigger communications and escalations at the protocol level within department, within function and cross-functionally.
• Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level.
• Coordinate the database lock preparation and monitoring of checks, such as data flow and derivations monitoring, for clinical data repository and triage issues according to report output.
• Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects, etc.
• Continually monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate at the trial level, program level, TA level and department Level.
• Performs tasks with minimal guidance from manager(s).
• Support and execute any role or task in the team when needed.

Primary responsibility in training new staff; CDMs, SCDMs and new LCDMs.

Qualifications:

• At least B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline with at least 3 years’ experience in clinical data management leading clinical trials and/or teams
• OR Associates Degree with at least 5 years’ experience in Clinical Data Management leading clinical trials and/or teams
• OR 8 years’ experience in Clinical Data Management leading clinical trials and/or teams.
• Knowledge of database structures and available tools to manage, extract, and report data is preferred.
• Fluent oral and written English language skills.
• Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
• Knowledge of applicable regulations and policies.
• Proficient overall working knowledge of the clinical development process.
• Good working knowledge of clinical practice and medical terminology.
• Ability to work cross functionally and as part of a team.
• 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 a manager.
• Ability to coordinate the work of others and influence decision making.
• Exceptional organizational, problem-solving and negotiating skills.
• Demonstrated excellent project management and leadership skills.
• Proficient in Microsoft Office, especially Excel.

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 COMPANY…

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

Zurich

The recently opened new location in Zurich focuses on accelerating research, data and commercialization of our medicines and vaccines. The new office will be staffed by teams working in strategic and operational roles in medical affairs, clinical development, access and marketing operations functions.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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.

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 for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
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):

Requisition ID:R153027