Innovative, Research-Focused German Pharma Company requires Clinical
Data Manager

 

 

We have been retained to search by our client for market leading
individuals to take on the role of Clinical Data Manager (CDM).

 

Our client is one of the most innovative and exciting pharmaceutical
companies operating in the global pharmaceutical market today,
headquartered at the heart of Europe.

 

They have initiated a process of expansion and re-organisation which
will enhance their capability to ensure the highest quality standards
across all sectors of their operation.

 

 

Primary Purpose of Position 

 

The main responsibilities of the Clinical Data Manager include:

 

*	Design Case Report Forms (CRFs), diaries and other data
collection forms 

*	Create and finalize the Data Management Plan 

*	Code adverse events and diagnoses as specified in the study
protocol 

*	Continuously monitor data flow 

*	Ensure that necessary tasks to achieve a clean database are
performed prior to database lock 

*	Appropriately file and archive essential documents 

*	Provide input into the selection and qualification of third
party vendors 

*	Assist in preparing agreements with third party vendors and
subsequent tracking of all deliverables 

*	The Clinical Data Manager contributes to other activities of the
Study Team as defined in the respective team profile.

 

Functional Roles & Responsibilities 

 

The following description documents specific process-related tasks for
which the Clinical Data Manager is accountable or responsible, and which
have not been covered in the profile of the Study Team.

 

In the process "Prepare data management" the CDM is:

 

*	Accountable: Create and review CRFs and other documentation
forms 

*	Accountable and Responsible: Conduct review meeting (if
applicable), and finalize /approve CRFs and other documentation forms 

*	Accountable: Create annotated CRF 

*	Accountable: Set-up DB, create, test and validate data entry
forms 

*	Accountable and Responsible: Decide whether E-diaries will be
used and create specifications for E-diaries 

*	Accountable: Create User Acceptance Test (UAT) plan, perform UAT
and write UAT report 

*	Accountable: Create EDT specifications (if applicable) 

*	Accountable: and Responsible: Review, finalize/approve EDT
specifications 

*	Accountable: Incorporate test data, transfer test DB, create and
review consistency checklist 

*	Accountable: and Responsible: Conduct review meeting of
consistency checklist 

*	Accountable: and Responsible: Create and update Data Management
Plan (DMP) 

*	Accountable: Review DMP 

*	Accountable: and Responsible: Conduct DMP Review Meeting and
approve DMP 

*	Accountable: Program consistency checks, and test and validate
consistency check program 

*	Accountable: Complete DB Approval Form and install Audit Trail

In the process "Conduct data management" the CDM is:

 

*	Accountable: Track, provide information on and scan received
documents

 

Functional Roles & Responsibilities 

 

*	Accountable: Perform double data entry incl. verification 

*	Accountable: Incorporate external data (if applicable) 

*	Accountable: Transfer DB on request (if applicable) 

*	Accountable: Prepare status reports 

*	Accountable and Responsible: Provide overall status reports 

*	Accountable: Perform coding of medication 

*	Accountable and Responsible: Perform coding of AEs and medical
history 

*	Accountable: Generate and distribute coding lists 

*	Accountable: Run consistency check program 

*	Accountable and Responsible: Clarify discrepancies with Safety
DB (if applicable) 

*	Accountable and Responsible: Update clinical DB (if applicable) 

*	Accountable and Responsible: Provide information on pregnancies
(if applicable) 

*	Accountable: Generate and distribute lists for medical review 

*	Accountable: Decide whether the consistency check program still
yields results after incorporation of last query 

*	Accountable: Decide whether there are any Self-Evident
Corrections (SECs) and incorporate them 

*	Accountable: Produce and provide Data Clarification Forms (DCFs)


*	Accountable: Update list of SECs performed 

*	Accountable: Perform QC and check whether any errors occur and
correct them 

*	Accountable: Create and provide final list of SECs performed 

*	Accountable and Responsible: Finalize DMP (if applicable) 

*	Accountable: Prepare DB for DB lock, check for additional
queries, lock and transfer DB 

*	Accountable and Responsible: Archive DB and study related
documentation

 

Interfaces with Other Departments/Functions

*	Science 

*	Operations 

*	Sourcing Mgmt 

*	Clinical Quality Assurance 

*	Drug Safety

 

External Interfaces

*	CROs and external providers

 

Additional requirements

Education

 

*	Bachelor's degree or diploma in Medical Documentation, Natural
Sciences or Informatics 

*	Experience in data management 

*	Understanding of regulations and guidelines (e.g. ICH, GCP.
European Clinical Trials Directive, Privacy rules [HIPPA]) 

*	Fluency in English is a must, fluency in German is advantageous

 

Industry-specific knowledge

Understanding of drug development process over different phases

 

 

Additional requirements

Personal skills & abilities

*	Organize work in a structured fashion with attention to detail
and compatible with other activities in the clinical project and / or
study 

*	Strong communication skills 

*	Proven ability to work in a team setting 

*	International and intercultural work experience 

*	Particularly attractive characteristics include: 


*	Non - complainer 

*	Smart 

*	Decision-maker 

*	Focused 

*	Quality conscience 

*	Technically sound 

*	Motivated

 

If you feel that this position could offer you a chance to develop your
career then feel free to forward me a copy of your CV in order to
facilitate a further confidential discussion.

 

 

AspirionPharma Ltd - Who are We?

 

AspirionPharma is a niche executive search firm specialising in the
provision of recruitment solutions to the global bio/Pharma and CRO
sectors. 

 

Utilising a developed and tested methodology we are able to provide
delivery on projects that other firms simply cannot.

 

Furthermore, we are positioned to provide additional "value-added"
benefits to our clients by acting as their "agents in the field" and
providing relevant industry information. We also ensure that they are
kept up to date (and in contact) with UQIs and industry leaders; this is
done through a tried and tested system of "Talent management".

 

Ash Butt LL.B Law (Hons) | Managing Director | AspirionPharma 

Direct Line      + 44 (0) 208 304 6538
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