Data Management Lead II/I (FSP) with Oncology - Poland, Romania, South Africa, UK, Hungary

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At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

This role can be flexibly based in Poland, Romania, UK or South Africa

The Functional Service Provider (FSP) division of Parexel is seeking a candidate for Data Management Lead with Oncology experience. The DML provides leadership in all aspects of Data Management. Manages timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Clinical, Medical Writing etc.) across all geographies. Data Management’s single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, cost and quality. The FSP Data Management Lead will work directly with the client leadership team and Parexel supporting clinical data analysts in client systems following client processes, as an extension of the client team. They will independently lead oncology trials and should have requisite experience.

Data Management Lead II/I:

• Provides Data Management leadership across assigned trial(s).

• 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 DM 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 DM hands on activities during the course of the study.

• Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation.

• Supports and assists Junior staff for assigned trials.

• Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner.

Ideal candidate will possess:

• Proven experience in Clinical Data Management.

• A minimum of two years of data management experience in Oncology trials.

• Significant vendor data reconciliation experience.

• Awareness of SDTM/CDISC/CDASH standards

• Proven record of coordinating and supporting project teams.

• University or college degree in life science, computer science, pharmacy, nursing etc.

• Competent in written and oral English

• Leadership skills that include building and leading global (virtual) teams, ability to work effectively with and motivate virtual teams, ability to negotiate and influence in order to achieve mutually beneficial results, ability to conduct root cause analysis in business problem solving and process improvement development.

• Understanding of Data Operations tasks, specifically within Data Management, Database Programming, Clinical Data Programming and relevant data standards.

• Sound awareness of relevant regulations, including ICH-GCP, 21CRF11.

• Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, RAVE, IVRS.

• Excellent interpersonal, oral and written communication skills.

• Excellent presentation skills.

• Strong customer focus, ability to interact professionally within a client organization.

A little about us:

Parexel is proud to be a leading Clinical Research Organization, with colleagues committed to make a difference. As a member of our global team, you’ll have discussions in an open environment—sharing expertise, promoting learning, and getting to know one another on a personal level. You’ll also experience supportive management that encourages career growth through consistent performance discussions and evaluations.