Senior Clinical Data Manager-Remote

Fortrea

jobsincanada.one

As a number one world contract analysis group (CRO) with a ardour for scientific rigor and many years of scientific improvement expertise, Fortrea offers pharmaceutical, biotechnology, and medical machine clients a variety of scientific improvement, affected person entry and know-how options throughout greater than 20 therapeutic areas. With over 19,000 employees conducting operations in additional than 90 international locations, Fortrea is reworking drug and machine improvement for companions and sufferers throughout the globe.

The Senior Medical Knowledge Supervisor leads research and takes duty for the event of the undertaking documentation, system set-up, information entry and information validation procedures and processes assigned to extra junior employees. Assume duty for all DM actions (from examine start-up to database lock) in keeping with consumer high quality expectations, inside undertaking timelines and budgets.

Key Duties:

  • Lead research together with (however not restricted to) a mixture of wholesome volunteer and affected person populations, multi-site, complicated protocol design, sturdy consumer administration required or diminished timelines. Capability to prepare and successfully prioritize workload and deliverables.
  • Because the Examine Supervisor, be accountable for all DM deliverables as assigned per the established timeline; offering instruction to their DM examine staff(s) and evaluation of their examine staff’s output to make sure the best high quality, whereas adjusting useful resource allocations accordingly.
  • Be sure that all allotted tasks are carried out in strict accordance with the related protocols, world harmonized SOPs, and the required requirements of GCPs.
  • Work with the Mission Supervisor(s) or FSP Lead (or designee) to construct timelines to fulfill contracted milestones by speaking with leads in several disciplines and the total undertaking staff as obligatory, together with at examine initiation conferences.
  • Present DM undertaking staff management and accountability; leads information targeted inside undertaking staff conferences; meets regularly with the examine leads of EDC Design, SAS Programming, Statistics, and PK to make sure that all deliverables are deliberate and coordinated intradepartmental; proactively identifies potential dangers/mitigations, successfully communicates data-driven discussions in an effort to obtain database lock dates; retains the Mission Supervisor or FSP Lead (or designee) apprised of undertaking progress.
  • Preserve consciousness of different Biometrics useful group deliverables to have the ability to help threat and mitigation methods, together with influence on DM assets or deliverables and seek the advice of with Mission Supervisor (or designee) and/or useful group administration as obligatory.
  • Maintain Mission Supervisor (or designee), Biometrics administration staff and/or sponsor providers knowledgeable of pertinent undertaking or sponsor associated info (i.e., price range standing, work scope modifications, timeline impacts).
  • Coordinates the receipt and stock of all information associated info, from scientific websites and distributors as acceptable in an effort to meet timelines for deliverables. Guarantee all acceptable documentation and procedures are carried out upon undertaking completion.
  • Develop and keep consumer relationships and evaluation consumer satisfaction surveys. Implement acceptable motion plans together with driving course of enhancements and staff coaching.
  • Monitor scope modifications and work with the Mission Supervisor or FSP Lead (or designee) to make sure that Sponsor approval is acquired, and the scope change processed.
  • Offers management, mentorship, and training in DM associated scientific trial processes, division technical capabilities, and related turnaround durations to the interior examine staff.
  • Present help to DM supervisors and managers on the efficiency analysis of different staff members, present constructive suggestions to assist in profession improvement, interpersonal expertise and achievement of competency requirements.
  • Accountable for studying new DM applied sciences and utilized processes, conserving updated with business extensive know-how and feasibility for course of enchancment at Fortrea.
  • Ensures service and high quality meet agreed upon specs per the DMP and scope of labor.
  • Have enter in writing, reviewing, and updating SOPs and related paperwork as required.
  • Preserve correct data of all work undertaken.
  • Carry out reconciliation of the scientific database in opposition to security information, laboratory information or some other third-party information as acceptable. Make the most of native laboratory programs and batch information load amenities the place acceptable.
  • Symbolize DM and the place obligatory general Biometrics in new enterprise alternatives.
  • Attend and motion consumer or inside audits as acceptable and resolve all points inside an acceptable timeframe. Tackle consumer feedback with the examine staff.
  • Works with administration staff to develop and implement directional technique by offering technical enter into discussions and rolling out coaching/mentorship to DM employees (as required).
  • Actively promote Biometrics providers to sponsors at any time when potential.
  • Serves as undertaking supervisor for stand alone information tasks.

Training & Expertise:

  • College / school diploma (life sciences, well being sciences, info know-how or associated topics most well-liked).
  • Expertise and/or schooling plus related work expertise, equating to a bachelor’s diploma shall be accepted in lieu of a bachelor’s diploma.
  • 8 years of mixed early or late-stage DM expertise with minimal 2 years of lead information administration expertise and a minimum of 2 years technical mentoring expertise.
  • Minimal of 1 yr of medical machine expertise most well-liked
  • Confirmed expertise in dealing with buyer negotiations and expertise with managing Scope of Work and budgets.
  • Thorough data of scientific trial course of, DM, scientific operations, biometrics, and system purposes to help operations.
  • Confirmed capability to steer by instance on undertaking methods and achievement of division objectives, aims and initiatives and to encourage staff members to hunt options.
  • Working data of the connection and regulatory obligation of the CRO business with pharmaceutical/biotechnological firms.
  • Time administration talent and talent to stick to undertaking productiveness metrics and timelines.
  • Capability to work in a staff setting and collaborate with friends.
  • Capability to mentor junior members of the division, offering SME steering on DM practices,
  • Expertise of representing DM in bid protection conferences, offering revolutionary options to fulfill consumer wants.
  • Good organizational capability, communication, and interpersonal expertise.
  • Constructive problem-solving angle whereas deadline targeted with time calls for, incomplete info or surprising occasions.

Pay Vary: $100,000-120,000

Advantages: All job gives shall be based mostly on a candidate’s expertise and prior related expertise, relevant levels/certifications, in addition to inside fairness and market information. Common, full-time or part-time staff working 20 or extra hours per week are eligible for complete advantages together with: Medical, Dental, Imaginative and prescient, Life, STD/LTD, 401(Okay), ESPP, Paid time without work (PTO) or Versatile time without work (FTO), Firm bonus the place relevant. For extra detailed info, please click on right here. Utility deadline February 23, 2024.

#LIREMOTE

Fortrea is actively in search of motivated problem-solvers and artistic thinkers who share our ardour for overcoming obstacles in scientific trials. Our unwavering dedication is to revolutionize the event course of, guaranteeing the swift supply of life-changing concepts and therapies to sufferers in want. Be part of our distinctive staff and embrace a collaborative workspace the place private development is nurtured, enabling you to make a significant world influence. For extra details about Fortrea, go to www.fortrea.com.

Fortrea is proud to be an Equal Alternative Employer:

As an EOE/AA employer, Fortrea strives for range and inclusion within the workforce and doesn’t tolerate harassment or discrimination of any sort. We make employment choices based mostly on the wants of our enterprise and the {qualifications} of the person and don’t discriminate based mostly upon race, faith, shade, nationwide origin, gender (together with being pregnant or different medical circumstances/wants), household or parental standing, marital, civil union or home partnership standing, sexual orientation, gender id, gender expression, private look, age, veteran standing, incapacity, genetic info, or some other legally protected attribute. We encourage all to use.

For extra details about how we acquire and retailer your private information, please see our Privateness Assertion. 

Read Full Description

Apply
To assist us monitor our recruitment effort, please point out in your cowl/motivation letter the place (jobsincanada.one) you noticed this posting.

Leave a Reply