Lead Clinical Data Manager I

Covance - Montréal, QC (il y a 30+ jours)

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Job Overview:
Lead Data Manager (Clinical Data Manager)
Home-Based in Canada or USA
Get ahead in your career and make a difference in people’s lives
Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others.
If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.
In this role, you will: Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance , and completion activities and develop Data Management Plans and Quality Management (QM) Plans that will deliver accurate , timely, consistent, and quality clinical Coordinate the development and testing of data management systems edit I data validation checks) diagnost i cs) and special listings I procedures used as tools for the data review and discrepancy management activities. Review data acquisition conventions and data review guidelines I diagno stic specifications consistent with the clinical data model , [ statist i cal] analysis plans, and CRF (eCRF) completion Serve as the project and client liai son including management and provision of project specific data management status, cycle time, and productivity metrics.

Additional responsibilities include: Identify and implement solutions to project data management i ss ues and concerns, including proactive pr eve ntion strategies based on metrics and + Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications I monitoring conventions, Interact and collaborate with other project and specialty team members (clinical , programming, statistics, CDM technical s upport, drug safety , ) to support the set-up , maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data hand li ng and qua l Advanced planning and risk management for projects (i ssue escalation, resource management). Assist with goal creation and performance review assessment for data review project staff. En s ure project staff are trained and adhere to project-specific, global, standardized data management processes. Support achievement of project revenue and operating mar g in for data management activities to agreed target Identify areas for process and efficiency improvement and implement solutions on assigned projects. Maintain technical data management competencies via pa1ticipation in internal and external training seminars . Oversee the technical performance of the data revi ew proj ec t staff on achieving client satisfaction through delivery of quality data, on-time and on-budget. Develop and maintain strategic client relation s hips and receive client satisfaction su rveys and implement appropriate action plans as Support business development for data management time and cost estimates and prepar e and present to potential clients on global data management capabilities. Perform other duties as assigned by management. Review literature and research technologies/procedures for improving global data management practices.
Thrive personally and professionally as a Lead Data Manager
Working at Covance, you can bring your skills to the team and expect comprehensive training so that you can continue to grow in your career. You will serve as the technical leader on all projects and identify and implement solutions for our clients in data management.
We also offer a competitive benefits package that takes care of you. This includes medical and dental insurance as well as tuition reimbursement, a 401(k) plan with a generous company match, PTO days along with short and long-term disability and life insurance.
Why choose to work at Covance Make a direct impact in the lives of patients Become successful in the position with exceptional training Join a high-energy and team-driven workplace Open up new opportunities for career growth

What we’re looking for
Lead Data Managers are the most successful at Covance with: 5+ years of Clinical Data Management experience and a minimum of 1 year of leading studies in a CRO setting. Combination of CRO/Pharma is acceptable. Bachelor’s degree; additional relevant work experience considered in lieu of degree. Full Experience including study start up, initiation, close out etc. Demonstrated skill for technical management of studies with 5+ staff. Experience with Database Build; eCRF creation; UAT experience. Demonstrated mentoring/delegation, communication and interpersonal skills
Get to know Covance
At Covance, we value your unique point of view and bold ideas to advance modern healthcare. Join our team and see how our collaborative work environment along with mentoring, training and career development can help you be successful at work and in your personal life.
Together, let’s shape new possibilities for your career and advance healthcare around the world. Education/Qualifications:

Education Required:
Un i versity/col le ge degree ( life science, pharmacy or related subject preferred) , or cert ificati on
in a related a lli ed h ealth profession from an appropriately accredited institution (e.g., nursing certification, medical o r l abora tory t ec hnology).
Additional relevant work experience will be cons id ered in lieu of formal qualific
Broad knowledge of drug development processes.
Understanding of global clin ical development bu dgets and rel ationship to productivity targets.
Knowledge of effective clinica l data management practices.
Knowledge of time and cost es timat e development and pricing strategies.
Thorough knowledge of TCH Guidel in es and GCP in c ludin g international regulatory requirements for the conduct of clinical development program s, especially as related to data handling and processing. Experience:

Experience Required:
Mi nimum five (5) years relevant wo r k exper i enc e in d a ta manag e men t wit h approxima t e l y one ( 1 ) yea r tech ni ca l supe r v i so r y ex p er i ence t o i nc lu de data m a n agement, clinica l operations, and know l edge of severa l t h erape ut ic a reas.
D e m on s tr ated sk ill fo r t ec h nica l ma n a ge m e n t of staff excee din g 5 e mployee s .
Fina n ci a l mana ge m en t of gross reve nu es in excess of $250K p e r year.
Exce ll e n t ora l and wr itt e n co mm u n ication and pr esentatio n ski ll s .
In d ept h know l edge of c lini ca l t r ia l process and d ata m a n agemen t , cli n ica l operat i on s, b i omet r ic s , q u a li ty m anage m e n t, a n d syste m s applicat i ons to suppo r t operat i o ns.
Worki n g know l edge of t h e r e l at i o n s hip a nd regu l atory ob l igatio n of the CRO indu s try w ith p h a r mac e ut i ca l I bi otechno l og i ca l companies.
Ability to lead by examp l e teams on project strategies and achievement of depa11ment goals, objectives, and initiatives and to encourage team members to seek solutions.
Demonstrated man ager i al and interpersonal sk ill

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.