Project Data Manager (Europe)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Project Data Manager (PDM) to join our A-team (hybrid*/remote). As a PDM at Allucent, you are responsible to lead and oversee data management activities, timelines and finances of the Allucent Data Management (DM) department. This position manages and coordinates DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.  

Additionally, this position acts as a Project Manager and is responsible for the overall coordination and management of Biometrics standalone projects, large and complex trials and/or multiple projects belonging to one client.

The PDM is a member of the Data Management staff.

In this role your key tasks will include{​{:}

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• Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Biostatistics and if applicable other functional groups, such as Project Management, Clinical Operations) and externally (e.g. sponsors, vendors (EDC, external data), investigational sites)
 
• As a Project Manager for Biometrics stand-alone studies, the Project Data Manager will{​{:
}
• } Lead and coordinate the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contra
c
• t Create and execute project management plans required for project delivery and in accordance with established process
e
• s Establish requirements for and ensures project-specific training plan for internal team membe
r
• s Establish clear communication lines and escalation pathways, communicate with project stakeholders, both internally (e.g. Clinical Programmers, Data Scientists, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data) and other external parties)
 
•   Establishes requirements for and ensures project-specific training plan for internal team membe
r
• s Establish project risk management plan with input from client and functional stakeholders and oversee adherence and updates throughout the project lifecyc
l
• e Lead internal meetings with internal team members and external meetings with sponsor, and third party (data) vendors, including Kick Off Meetings (KOM) and Investigator Meetings based on project sco
p
• e Provide support for vendor identification, qualification and selection and manage vendo
r
• s Manage vendors and vendor relationships as required for project delive
r
• y Arrange, maintain and circulate project progress and status repor
t
• s
•   In addition, as a Project Manager for Biometrics stand-alone studies and/or large, complex or multiple studies with same client, the Project Data Manager will{​{
  :
  }
}
• Lead the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contr
a
• ct Ensure overall consistency across all client studies within a set of projects; this especially relates to the DM activities; Data Management Plan (DMP), CRF design, data cleaning and query management) and for Biometrics stand-alone projects also includes statistical deliverables (SAP, TL
F
• s) Lead internal meetings with internal project team members. Support and participate in external meetings with sponsor, including Kick Off Meetings (KOM) and Investigator Meetings based on project sc
o
• pe Interact, negotiate and influence internal and external team members in a professional manner and with successful outco
m
• es Ensure effective and efficient resource utilization across projects and progr
a
• ms Manage the study budget, evaluate financial project health and manage monthly status updates for invoicing. Participate in monthly project review meeti
n
• gs Proactively recognize and address any changes in scope. Liaise to execute contract amendme
n
• ts Oversee Sponsor relationsh
i
• ps Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eC
O
• A) May support operational Data Management activities, also to ensure and assess qual
i
• ty Oversee and ensure the Trial Master File for DM services in scope is kept up to date and audit/inspection re
a
• dy Contribute to other areas of business as requi
r
• ed Research, propose and lead initiatives for improving efficie
n
• c
y
• Actively support to staff learning & development within the comp
a
• ny Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussio
n
• s  Represent the company through active participation at professional meetings, webinars or semin
a
• rs Provide and coordinate Data Management training for relevant staff. Support in development of new training materi
a
• l Participate in the interview process for new recrui
t
• s  Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Senior Directors, for further alignment and improvement of current process
e
• s
 
• Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management Sys
t
• em
• .. Assure good communication and relationships with (future) clie
n
• ts Contribute to and take part in client evaluations and vis
i
• ts Support in preparation of new proposals and budgets for Data Management servi
c
• es Support Business Development (BD) in preparing and providing presentations to potential and existing clients through attendance at capabilities and/or bid defense meeti
n
• gs Provide input into tools and templates to support costing and biddi
n
• g 
.
• .. Contribute to other areas of business as requi
r

ntsTo be successful you will possess{​

{
• :}} Life science, healthcare degree and/or combination of education and experi
e
• nce Minimum 8 years of relevant work experience in Clinical Data Management or related experience within Biometr
i
• cs Minimum 8 years of relevant experience in related clinical trials environ
m
• ent Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirem
e
• nts Good understanding of Medical Termino
l
• ogy Experience as DM Lead on several studies and experience in covering all phases of a clinical study (start up, conduct and database lock). Worked on multiple indications and clinical phases (I
-
• IV) Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documenta
t
• ion Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these mo
d
• els Client management experie
n
• ce  Experience in developing data management stand
a
• rds Strong written and verbal communication skills including good command of English langu
a
• ge Representative, outgoing and client focu
s
• ed Ability to work in a fast-paced challenging environment of a growing com
p
• any Proficiency with various computer applications such as Word, Excel, and PowerPoint requ
i
• red Administrative excellen
c
• e  Attention to detail, strong technical, analytical and problem-solving ski
l
• ls  Strong project management ski
l
• ls  Ability to translate guidelines, rules and regulations in clear and usable recommendat
i
• ons Ability to simplify complex issues into understandable conc
e
• pts Excellent organizational, negotiating and motivational sk
i

fitsBenefits of working at Allucent include{

​
• {:}} Comprehensive benefits package per loc
a
• tion Competitive salaries per loca
t
• ion Departmental Study/Training Budget for furthering professional develop
m
• ent Flexible Working hours (within rea
s
• on) Opportunity for remote/hybrid* working depending on loc
a
• tion Leadership and mentoring opportuni
t
• ies Participation in our enriching Buddy Program as a new or existing emp
l
• oyee Internal growth opportunities and career progres
s
• ion Financially rewarding internal employee referral pro
g
• ram Access to online soft-skills and technical training via GoodHabitz and internal plat
f
• orms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on proj
e
• cts Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding empl
o

y

ees Disclaimers

{​{:}}*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global of

f

ices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resou