Job Description

The (Senior) Data Management Lead (FSP) provides leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming. The Data Management Lead manages the delivery of all relevant data operations activities from database setup through database lock and data transfers.

General areas of responsibility include: coordination of the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met - specifically in terms of timeliness, financial management and quality.
May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned.

You will contribute by:
Providing Data Management leadership across assigned trial(s) acting as the Trial Data Manager where needed
Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.
Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards
Performs Data Management activities for start up of a study including preparing the eCRF, CCG's where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT)
Manage local lab set up for the Clinical Database as applicable
Performs Data Management hands on activities during the study
Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation
Supports and assists Junior staff for assigned trial
Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner
Provides effective input into DM initiatives and innovations for quality, efficiency, and continuous improvement in scientific and operational excellence
Tracks and reports status and progress for assigned trials, indications, or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).
Ensures adherence to GCP, Data Management standards, SOPs/WPS and process guidelines.Qualifications

Education
(minimum/desirable): University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree.
Languages: Fluent English (oral and written).
Experience/Professional requirement:
Ability to work under pressure demonstrating agility through effective and innovative team leadership
Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
Excellent problem-solving skills
Ideally 4 years' experience in Drug Development with at least 3 years' in Clinical Data Management
Excellent verbal and written skills.Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.