Senior Clinical Trial Data Manager at Genmab

4. October 2021 14:48 by Lene Haastrup in

Here you find the position:

further description by following the link above:

The Role

 

Genmab is looking for a highly motivated and experienced Senior Clinical Trial Data Manager with a minimum 5-10 years’ experience from the Pharmaceutical industry to be part of Clinical Data Management within Global Clinical Operations.

 

The Senior Clinical Data Manager will be responsible for proactively securing reliable, timely, and high-quality clinical trial data for Genmab trials by providing clinical data management oversight of the conduct of the trials. The Data Manager will provide a leadership role in the oversight of the data cleaning process as well as oversight of data quality and detection of data trends and serves as the main contact for all data management activities for Clinical Trial Teams.  The Senior Data Manager provides strategic data management expertise to ensure high-quality data deliverables are achieved within timelines and budget.

 

You will, in close collaboration with the Biometrics Vendor partner, be accountable for all end-to-end Data Management activities and deliverables. The Data Manager will provide oversight of all vendors conducting data management activities on behalf of Genmab.  Further, the Senior Data Manager will support the development and optimization of processes and tools to enable success of the Clinical Operations department.

 

In this position, you will be reporting to a Data Management Team Lead in Clinical Data Management. The Senior Clinical Data Manager will work closely with the Clinical Trial Team to ensure successful trial conduct.

Further description in the link above.

DADM Conference 23-September 2021

7. September 2021 13:28 by Lene Haastrup in

 Dear all members of DADM

Here you find the program with link to the presentations.

59 members attended the conference and 25 attended the dinner.

DADM Conference 23-September 2021

Venue

Novo Nordisk
Vandtårnsvej 112
2860 Søborg

Contact

Frank Jensen

For questions

FNJE@novonordisk.com

 

 

Free of charge for members of DADM

(No show fee for dinner 200DKK)

 

Schedule

Activity

Speaker(s)

09.00-09.30

Welcome Coffee and light breakfast

 

All

09.30-10.00

Welcome & Intro

Presentation of the DADM board members

 

Katja Bernstein

Frank Jensen

 

DADM board

 

10.00-10.45

Presentation of focus groups, work and results

·       Sponsor oversight

·       Audit trail review  ATR FG at DADM 23SEP2021.pptx (2.69 mb)

·       Risk-based Data Cleaning

·       New groups?

 

 

 

Katja Bernstein

Jennifer Nielsen

Frank Jensen

Lene Haastrup 

10.45-11.15

Break

 

11.15-12.00

Interplay between Data Privacy and Good Clinical Practices

 

Bertrand Le Bourgeois, Président, PharMarketing GDPR Life Sciences

12.00-13.00

Lunch

 

13.00-13.45

Experimenting with innovation

 

 

 DADM_Experimenting_innovation_23Sep2021.pptx

 

 

 

 

Sofie Inari Castella, Director, Data Management Process and Innovation, Novo Nordisk

13.45-14.30

Fit4take-off

Moon-shot aspiration project.

Submit for authorities 4 days after LPLV

2021-09-23 Fit4take-off DADM.pptx (3.36 mb) 

Lars Kirk Knudsen, Manager, and Tine Troen, Principal Change Management Specialist, Trial Data Management

Novo Nordisk

14.30-15.00

Coffee break

All

15.00-15.45

 Decentralized Trial

DCT at Lundbeck final 23SEP2021.pdf (3.06 mb)

Jennifer Logue Nielsen, Senior Specialist, Clinical Data Management and

Alastair Clewlow, Senior Director, Digital Technology and Data Management

H. Lundbeck A/S

15.45-16.15

Wrap up and wishes for future activities in DADM

Frank Jensen

17:30

 

 

 

18:00

Pre-dinner drink

Meyers Spisehus  ·  Handelstorvet 10  ·  Entrance v/Magasin & Johannes Fog  ·  2800 Kgs. Lyngby

 Dinner

All

 

 

 

DADM Summer Meeting 2021

12. May 2021 11:23 by Administrator in

 

 We will meet by the stairs in front of Thorvaldsen's museum

 DADM Summer Arrangement 2021

 

Finally, we can meet face to face.

Therefore, we are pleased to announce that the DADM Board has arranged for a summer event:

 

Wednesday June 16 at 17.00-18.30.

 

First, we will discover Copenhagen, led by Hanne Fabricius, where we will take a tour outside of Christiansborg. Title: Slotsholmens historie: Forsvundne slotte, mystiske tunneler, og en gammel krigshavn.

 

 

This tour will be in English if required.

 

 

 

 

Following this, we are pleased to invite you for a dinner at Zeleste, on St. Strandstræde 6, 1255 Kbh. K

 

The dinner starts after the tour. The tour is from 17.00 to 18.30.

Please indicate on the invitation if you have any food allergy, that we need to think about.

Cancellation of dinner participation must be provided to the DADM Board no later than 10 am on the day before the event, by e-mailing to danskforeningfordatamangement@gmail.com.

In case of no show for the dinner, DADM will ask you to cover the loss.

Please register no later than Friday June 11, 2021

 

We look forward to seeing you all 😊

On behalf of the DADM Board

slides on focus groups

4. May 2021 15:36 by Lene Haastrup in

Dear all

Thank you for your great participation in celebration of DADM Anniversary.

Next initiative introduced is creation of focus groups. Three topics are chosen.

If you want to join one of the focus groups, then you send an e-mail to the facilitator below:

Frank, fnje@novonordisk.com, Risk-based data cleaning; 31-May-2021 15:30 to 16:30 on teams

Jennifer, JNNI@lundbeck.com, Audit trail review; 19th May 15.30 to 16:30 on teams

Katja, KABN@lundbeck.com, Sponsor oversight;  26th of May 2021 at 15.30 to 16.30 on teams

By participating in the focus group then you accept that your e-mail address is visible for the other members and the facilitator!

You can participate in one or more groups.

The date for our full day conference is planned to be Thursday 23th of September 2021.

The board is also investigating possibilities to arrange a more social event in June.

Further notice will be given.

The slides from the anniversary are found here

dadm_history_20_final.ppt (2.22 mb)

 

General meeting DADM 04 February 2021

9. January 2021 15:13 by Lene Haastrup in General
General Meeting 2021
The minutes will soon be available
 
Dear All,

Announcement/registration for the DADM General Meeting 2021 is now available!

The meeting will be held on the 04-February-2021 from 15:30-17:30. The event will be held online. When you register, you accept that the other participants can see your e-mail and name
After signing, you will get a Teams meeting invitation on the 03-February-2021.
Meeting venue: Teams

Agenda:
General Meeting – (45 mins)
1. Election of chairman
2. The President’s report
3. Presentation and approval of financial report
4. Presentation and approval of budget and activities including endorsement of membership fee
5. Election of Executive Officers, Alternating Officers, and Auditor
6. Proposed motions
7. Miscellaneous

• Break (15 mins)
8. Topic of the evening:
eClinical Solutions

Digital Transformation in Life Sciences: What it Means for Data Management (35 minutes of content)

 

Speakers Raj Indupuri (Founder and CEO), Robert Musterer (VP, Product Management), Sam Parnell (BD Director, Europe)

  • What is “Digital Transformation” – Other Industry Examples
  • Key Digital Trends in Life Sciences
  • Problem Statements
  • The technology ecosystem that enables Digital Transformation
  • What it means for Data Management – what does “Good” Look like
  • Intelligent Data Review – Modern data workbench that is available NOW
  • Old Way | New Way
  • Opportunities  & Upskilling for DM to speed this transformation  (How YOU can make this happen)
Sign up closed

Wishing you a happy New Year,

DADM Board

DADM_v3 eCS slides.pdf (1.21 mb)

DADM Conference 5th of October 2020

6. September 2020 10:37 by Lene Haastrup in

The availbe powerpoint presentaions are found under each subject in the program below.

Thank you for a good conference.

The DADM board is looking for more subjects to present this year.

If you have any ideas, please mail danskforeningfordatamanagement@gmail.com

Kind regards 

DADM board

 

 

--------------------------------------------------------------------------------------------------------------------------------------------

Despite the situation, DADM is still going strong. The rules in Pharma have forced us to hold the annual conference online. The conference will take place on 5th of October 2020.

We have collected several speakers and exiting topics, as you see in this program

After the event, you are invited for dinner in real life in Lyngby.

 

_________________________________________________________________________________

 

 

 

DADM Conference 05 October 2020

Venue

Only speakers and the board

 Novo Nordisk, Vandtårnsvej 108

Søborg

Contact

Frank Jensen

 

No dinner

 

Account number

1551 7952110490

(Danske Bank)

Contact

Lene Haastrup (treasurer)

 

Schedule

Activity

Speaker(s)

09.30-09.45

Welcome & Intro

 

Katja Bernstein & Frank Jensen

09.45-12.00

Audit Trail – what is the expectation from DHMA to the Sponsors

(see below)

Ib Alstrup, DHMA (Lægemiddelstyrelsen)

 IBAL_DKMA_QA.pptx (3.20 mb)

 

Questions and break

 

 

Highligths from the new eClinical Forum paper on Audit Trail review

Jennifer Logue Nielsen, Novo Nordisk

ATR_DADM_05OCT2020.pptx (4.40 mb)

 

Questions

 

12-13.45

Lunch break

 

13.45-14.30

Cloud Computing – in a GxP context

Questions 

Kasper Nørgaard Andersen, Senior Consultant, AlfaNordic

 

14.30-15.15

Data protection – in a clinical context

 

Data management and GDPR - what should you know?

The most recent news on status as a data controller or data processor and joint controllership

Requirements to agreements with suppliers, security breaches and why transfers of personal data to the U.S. may become a material challenge.

Questions 

Director, attorney (CIPP/E) Daiga Grunte-Sonne, Kromann Reumert

 Data_management_and_GDPR.pptx (2.94 mb)

15.15-16.00

Investigator Experience from Participation in a Clinical Study

Investigator Christine Dali

PI_experiences_presentation_Oct_5_2020.pptx (2.36 mb) 

 

 Including questions

 

 

 

 

 

 

 

17:30

 

18:00

 

Dinner cancelled

All

 

 

IB Alstrup, DADM questions raised on beforehand:

Decommisioning:

  • How should sponsors document the system functionality? Are PDF files including the data and pictures of how they were gathered (blank CRFs) sufficient?
  • Investigators access to data. Is it fine to revoke the access when sponsor have received acceptance of receipt of the hard drive containing the data from sites?
  • Audit trail. Is it fine to have this as PDF file only (hard to search for specific data changes)?

Ongoing:

  • How much review of the audit trail is expected from the regulators? (Please provide examples of which kind of data and reviews you will expect us to look at) Is it sufficient to look for trends ‘by sites’ and ‘by data items’?

 New devices/ways of collecting data:

  • Before starting working with a new system, what QC is expected to the audit trail functionality? How is this dependent of whether the system is seen as SAAS (Software As A Service)
  • BYOD (Bring Your Own Device). What to focus on when documenting why data is collected this way? – When is better patient compliance outweighing the risk for ‘wrong’ data (registered by someone else or local setting changed)?
  • Automatic data collection tools (e.g. activity trackers). What to focus on when documenting which data are used? In general a data mining is taking place and the algorithm is not known to the sponsor. Do we need to archive the raw data, or could the data mining result be defined as raw data?
  • Any new device. What to focus on when documenting why this device is used. What kind of mitigations are expected to see?
  • How are the documentation dependent on the way sponsors use the software? SAAS or sponsor ‘owned’ – and in what category do we see the mobile apps?

 

 

 

 

 

 

 

 

Presentations from DADM conference 5 October 2020

9. March 2020 13:10 by Lene Haastrup in Presentations

Ib Alstrup DKMA Audit trail Review- the expectation from DHMA to the Sponsors: -   IBAL_DKMA_QA.pptx (3.20 mb)

 

Jennifer Logue Nielsen. Novo Nordisk: Highligths from the new eClinical Forum paper on Audit Trail Review    ATR_DADM_05OCT2020.pptx (4.40 mb)

Daiga Grunte-Sonne, Kromann Reumert Data Protection - in a clinical context     Data_management_and_GDPR.pptx (2.94 mb)

 

 Christine Dali, Orphazyme: Investigator experience from Participation in a Clinical Study    PI_experiences_presentation_Oct_5_2020.pptx (2.36 mb)

General meeting DADM 26 February 2020 Minutes

4. March 2020 12:36 by Lene Haastrup in General, Meetings

General meeting DADM 26 February 2020

 Minutes

 

 

The General meeting was held at Lundbeck with participation of 34 people.

 

Conductor: Carsten Junge

Reporter: Gitte Kruse            

 

The notice for the general meeting have been send out in a timely manner according to the valid regulation.

 

President report

Ibrahim Kamstrup-Akkaoui went through the annual report and informed of all the activities during 2019.  The President report was hereafter approved.

 

Financial result

The financial result was presented by the cashier and was hereafter approved without any comments.

 

Budget 2020

The budget was presented by the cashier and membership fee suggested to remain at 350 kr. per person. The budget for 2020 was approved without comments.

 

Election of executive committee

The executive committee as it looks after election is listed below. A few committee members were replaced per request.

 

  • Britt Bech Andersen (re-elected 2 years)
  • Mette Ravn (re-elected 2 years)
  • Frank Jensen (re-elected 2 years)
  • Poul Knoblauch (re-elected 2 years)
  • Gitte Kruse (not on election)
  • Lene Haastrup (not on election)
  • Katja Bernstein (not on election)
  • Kim Sonne (new committee member. Replaces Bo and is therefore only elected for the remainder of Bo’s election period and will be on election again next year)
  • Mette Schledermann Larsen (new committee substitute)

 

  • Bo Roat Jørgensen (left the executive committee)
  • Ibrahim Kamstrup-Akkaoui (left the executive committee)

 

  • Lisbet Groes continues as auditor.

 

Correction of wording in $4

A minor wording in $4 in the regulation regarding compensation, was by mistake not updated. The suggestion it-self was already approved in 2017, so this only relates to the wording in $4. The re-wording was approved

Proposed motions

None

Consolidating

The executive committee was consolidated with

Chairman Katja Bernstein

Treasurer Lene Haastrup

Secretary Gitte Kruse.

DADM Conference 2018 Presentations

10. October 2018 14:47 by Ibrahim Kamstrup-Akkaoui in

Dear All,

Thanks for your active participation in the conference and hope that it lived up to your expectations. Remember that you also have an influence on the topics and is welcome to share too.

Please find the presentations from the conference below.

Best regards,

DADM Board

 

DADM_encapsia.pdf (855.39 kb)

DADM_Knowit_Robotics.pdf (1.84 mb)

DADM_PD_Ferring.pptx (716.20 kb)

DADM_PD_Larix.pptm (1.82 mb)

DADM_SAS.PDF (4.07 mb)