Description
Job Location: Maidenhead SL6, UK
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Company Overview:
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Job Overview:
Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets. Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors. Work directly with Sponsors to understand their direct requirements and lead implementation of those requirements. Regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea. The Senior Clinical Data Manager will work with the leadership team to provide guidance, mentoring and training to DM to ensure best working practices are maintained.
Summary Of Responsibilities:
- Lead studies including (but not limited to) a combination of healthy volunteer and patient populations; multi-site; complex protocol design; strong client management required or reduced timelines.
- Ability to organize effectively prioritize workload deliverables.
- As the Study Manager, be accountable for all DM deliverables as assigned per established timeline; providing instruction to their DM study team(s)
and review of their study team’s output ensuring highest quality while adjusting resource allocations accordingly.
- Ensure that all allocated projects are carried out in strict accordance with relevant protocols global harmonized SOPs specified standards GCPs.
- Work with Project Manager(s) or FSP Lead (or designee) build timelines meet contracted milestones by communicating leads different disciplines full project team necessary including at study initiation meetings.
- Provide DM project team leadership accountability; lead data focused internal project team meetings; meet frequently study leads EDC Design SAS Programming Statistics PK ensure all deliverables planned coordinated intradepartmental proactively identify potential risks/mitigations effectively communicate data-driven discussions order achieve database lock dates keep Project Manager FSP Lead (or designee) apprised project progress.
- Maintain awareness other Biometrics functional group deliverables support risk mitigation strategies including impact on DM resources deliverables consult Project Manager (or designee)/functional group management necessary.
- Keep Project Manager (or designee), Biometrics management team sponsor services informed pertinent project sponsor related information budget status work scope changes timeline impacts.
- Coordinate receipt inventory all data related information from clinical sites vendors appropriate meet timelines deliverables ensuring appropriate documentation procedures performed upon completion projects.
- Develop maintain client relationships review client satisfaction surveys implement appropriate action plans driving process improvements training track scope changes work Project Manager FSP Lead or designee ensure Sponsor approval received scope change processed.
- Provide leadership mentorship coaching in DM related clinical trial processes department technical capabilities associated turnaround durations internal study teams provide support supervisors managers performance evaluation other members constructive feedback aid career development interpersonal skills achievement competency standards accountable learning new technologies applied processes keeping up date industry wide technology feasibility process improvement at Fortrea ensures service quality meet agreed upon specifications DMP scope work have input writing reviewing updating SOPs associated documents required maintain accurate records work undertaken perform reconciliation clinical database against safety laboratory third-party appropriate utilize local systems batch load facilities where appropriate represent overall Biometrics new business opportunities attend action audits resolve issues within timeframe address comments study teams works management develop implement directional strategy providing technical input discussions rolling out training/mentorship staff required actively promote services sponsors whenever possible performs other related duties assigned by management.
Qualifications:
(Minimum Required)
University / college degree. Experience education plus relevant work experience equating bachelor’s degree accepted lieu bachelor’s degree.Fortrea may consider relevant equivalent experience lieu educational requirements.Language Skills Required: Speaking/Writing/Reading English required.
Experience:
(Minimum Required)
8 years combined early late-stage experience minimum 2 years direct sponsor management at least 2 years technical mentoring experience proven handling customer negotiations managing Scope Work budgets thorough knowledge trial process operations biometrics applications support operations proven ability lead example strategies achievement goals objectives initiatives encourage members seek solutions working knowledge relationship regulatory obligation industry pharmaceutical/biotechnological companies time management skill ability adhere productivity metrics timelines ability collaborate peers mentor junior members department providing SME guidance practices experience representing bid defense meetings innovative solutions meet needs good organizational communication interpersonal skills constructive problem-solving attitude deadline focused time demands incomplete information unexpected events.
Preferred Qualifications Include:
University / college degree life sciences health sciences information technology subjects preferred thorough knowledge Fortrea overall structure organization Standard Operating Procedures SOPs four more years Electronic Data Capture experience.
Physical Demands/Work Environment:
Role office remote-based associated risks repetitive strain injury keyboard operation eye strain VDU screen operation potential travel cross-site support training needs meetings up 10% time up 50% requiring overnight stay.Fortrea actively seeking motivated problem-solvers creative thinkers share passion overcoming barriers trials unwavering commitment revolutionize development process ensuring swift delivery life-changing ideas therapies patients need join exceptional team embrace collaborative workspace personal growth nurtured enabling make meaningful global impact.For more information about Fortrea visit www.fortrea.com.
Equal Opportunity Employer Statement:
Fortrea Is Proud To Be An Equal Opportunity Employer.As an EOE/AA employer strives diversity inclusion workforce does not tolerate harassment discrimination kind make employment decisions based needs business qualifications individual do not discriminate based race religion color national origin gender pregnancy medical conditions needs family parental status marital civil union domestic partnership status sexual orientation identity expression personal appearance age veteran status disability genetic information legally protected characteristic encourage apply.For more information about how collect store personal data please see Privacy Statement.If require reasonable accommodation complete job application pre-employment testing interview otherwise participate hiring process please contact:. Please note e-mail address only job seekers requesting accommodation do not use check status application.Lifelancer is talent-hiring platform Life Sciences Pharma IT connects talent opportunities pharma biotech health sciences healthtech IT domains.For details find similar roles check Lifelancer link https://lifelancer.com/jobs/view/d09ca43f69aad102add8701414fc0ad6 Apply Lifelancer Platform