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Manager, Trial Master File - Remote, USA
Deerfield, IL
Job Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a TMF Manager in Remote, USA. The TMF Manager demonstrates a good understanding of TMF processes and awareness of evolving regulatory requirements related to records management to support the development and delivery of a TMF Operations strategy. The TMF Manager is responsible for creating and updating tools and processes which will support clinical study teams across multiple functional areas to maintain a complete and contemporaneous TMF. The TMF Manager collaborates with a diverse set of stakeholders and leaders across various functions who utilize the TMF, whilst promoting TMF best practices.
RESPONSIBILITIES
* Collaborates with multiple stakeholders and leaders across functions of relevant departments and additional eTMF users, as required to develop strategy for the study TMF, provides input to study risk assessment and vendor selection.
* Provides an advanced level of knowledge to cross functional TMF business representatives and/or Business Partners in TMF issue resolution.
* Drives and leads the development of study-specific, cross-departmental TMF Plans and TMF Indexes coordinating cross functional Sponsor and CRO teams.
* Leads, develops and delivers high standard TMF process and eTMF system training
* Collaborates with Clinical Project Manager(s), TMF Operations Lead and other TMF Operations team members to develop study TMF oversight and TMF inspection readiness strategy.
* Leads and develops TMF process improvement and applies expertise to keep TMF current and industry leading.
* Executes TMF oversight at a global level by generating TMF-relevant metrics from the eTMF system and escalating any cross-organizational issues to functional leaders and study teams as necessary.
* Generates individual, departmental, and organizational performance metrics, escalates issues to TMF Operations Lead and departmental/organizational representatives as part of the TMF oversight.
* Promotes use of Sponsor eTMF with cross functional teams including Managers, Senior Managers and partners, by building strong professional relationships and networks among peers and colleagues
* Supports Sponsor eTMF business owner in system management to ensure compliance with all associated SOPS.
* Supports Sponsor eTMF business owner in the role of eTMF business administrator, carrying out required eTMF activities including eTMF user access and requests for changes to TMF documents
* Supports TMF Operations Lead in development and execution of key performance indicators and key risk indicators as part of the study, organizational and global oversight
* Ability to act as deputy for TMF Operations Lead required, on TMF Ops related activities and tasks.
EXPERIENCE
* Experience working in a TMF environment at a Sponsor or CRO company
* Extensive and current knowledge in Trial Master File Regulations, TMF Reference Model, and evolving industry standards and best practices
* Ability to show initiative to solve complex issues with regards to ways of working and bring innovative thinking to issues that arise
* Ability to work independently and work well in a global team environment to support overarching TMF Ops team deliverables
SKILLS:
* Strong communication skills
* Ability to motivate others and drive decision making
* Attention to detail and methodical approach
* Flexible and adaptable to a fast-changing environment
* Excellent time management and organizational skills
* Strong track-record of developing TMF Plans and TMF Indexes
* Excellent computer skills (Microsoft Office suite, SharePoint use)
* Experienced working in an eTMF system (preferably Veeva Clinical Vault) as an end user, business, or system administrator
* Experience supporting Global GCP Regulatory inspections and internal audits
* Able to carry out responsibilities with minimal supervision
EDUCATION
Minimum of Educated to degree level or equivalent
To be a best-fit your strengths must include:
* Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
* Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
* Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
* Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
* Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
* Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
We are currently searching for a skilled professional to join a well-known client's team as a TMF Manager in Remote, USA. The TMF Manager demonstrates a good understanding of TMF processes and awareness of evolving regulatory requirements related to records management to support the development and delivery of a TMF Operations strategy. The TMF Manager is responsible for creating and updating tools and processes which will support clinical study teams across multiple functional areas to maintain a complete and contemporaneous TMF. The TMF Manager collaborates with a diverse set of stakeholders and leaders across various functions who utilize the TMF, whilst promoting TMF best practices.
RESPONSIBILITIES
* Collaborates with multiple stakeholders and leaders across functions of relevant departments and additional eTMF users, as required to develop strategy for the study TMF, provides input to study risk assessment and vendor selection.
* Provides an advanced level of knowledge to cross functional TMF business representatives and/or Business Partners in TMF issue resolution.
* Drives and leads the development of study-specific, cross-departmental TMF Plans and TMF Indexes coordinating cross functional Sponsor and CRO teams.
* Leads, develops and delivers high standard TMF process and eTMF system training
* Collaborates with Clinical Project Manager(s), TMF Operations Lead and other TMF Operations team members to develop study TMF oversight and TMF inspection readiness strategy.
* Leads and develops TMF process improvement and applies expertise to keep TMF current and industry leading.
* Executes TMF oversight at a global level by generating TMF-relevant metrics from the eTMF system and escalating any cross-organizational issues to functional leaders and study teams as necessary.
* Generates individual, departmental, and organizational performance metrics, escalates issues to TMF Operations Lead and departmental/organizational representatives as part of the TMF oversight.
* Promotes use of Sponsor eTMF with cross functional teams including Managers, Senior Managers and partners, by building strong professional relationships and networks among peers and colleagues
* Supports Sponsor eTMF business owner in system management to ensure compliance with all associated SOPS.
* Supports Sponsor eTMF business owner in the role of eTMF business administrator, carrying out required eTMF activities including eTMF user access and requests for changes to TMF documents
* Supports TMF Operations Lead in development and execution of key performance indicators and key risk indicators as part of the study, organizational and global oversight
* Ability to act as deputy for TMF Operations Lead required, on TMF Ops related activities and tasks.
EXPERIENCE
* Experience working in a TMF environment at a Sponsor or CRO company
* Extensive and current knowledge in Trial Master File Regulations, TMF Reference Model, and evolving industry standards and best practices
* Ability to show initiative to solve complex issues with regards to ways of working and bring innovative thinking to issues that arise
* Ability to work independently and work well in a global team environment to support overarching TMF Ops team deliverables
SKILLS:
* Strong communication skills
* Ability to motivate others and drive decision making
* Attention to detail and methodical approach
* Flexible and adaptable to a fast-changing environment
* Excellent time management and organizational skills
* Strong track-record of developing TMF Plans and TMF Indexes
* Excellent computer skills (Microsoft Office suite, SharePoint use)
* Experienced working in an eTMF system (preferably Veeva Clinical Vault) as an end user, business, or system administrator
* Experience supporting Global GCP Regulatory inspections and internal audits
* Able to carry out responsibilities with minimal supervision
EDUCATION
Minimum of Educated to degree level or equivalent
To be a best-fit your strengths must include:
* Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
* Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
* Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
* Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
* Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
* Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
Open
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