Innovative, Research-Focused German Pharma Company requires Clinical
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:
o Non - complainer
o Smart
o Decision-maker
o Focused
o Quality conscience
o Technically sound
o Motivated
If you feel that this role might be of interest, please contact me using
the email address below. Additionally, if you would like to set up a
confidential discussion regarding your career please send me through a
copy of your CV and a contact telephone number and we can set up a time
to talk.
Kindest regards
Abbi Cohen | Project Coordinator | AspirionPharma
Direct Line + 44 (0) 208 304 6538
Fax + 44 (0) 208 304 6549
Mobile + 44 (0) 792 119 7221
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www.aspirionpharma.com <http://www.aspirionpharma.com/>
AspirionPharma is part of the Aspirion Group of Companies
www.aspiriongroup.com <http://www.aspiriongroup.com/>
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