FSP Senior CTC(Shanghai)

4 weeks ago

Pu Dong Xin Qu, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

Description

of Roles and Responsibilities

• Trial and site administration :

o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)

o Ensure collation and distribution of study tools and documents

o Update clinical trial databases (CTMS) and trackers

o Clinical supply & non-clinical supply management, in collaboration with other country roles

o Manage Labeling requirements and coordinate/sign translation change request

• Document management:

o Prepare documents and correspondence

o Collate, distribute/ship, and archive clinical documents

o Assist with eTMF reconciliation

o Updating manuals/documents (e.g., patient diaries, instructions)

o Document proper destruction of clinical supplies.

o Prepare Investigator trial file binders

o Execute eTMF Quality Control Plan

o Obtain translations of documents

• Regulatory & Site Start-Up responsibilities:

o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

o Obtain, track and update study insurance certificates

o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

o Publish study results for GCTO and RA where required per local legislation

• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:

o Develop country and site budgets (including Split site budget) o Tracking, and reporting of negotiations

o Maintenance of tracking tools

o Contract development, negotiation, approval and maintenance (e.g. CTRAs)

o Update and maintain contract templates (in cooperation with Legal Department)

o Payment calculation and execution (investigators, vendors, grants)

o Ensure compliance with financial procedures ,

o Monitor and track adherence and disclosures

o Budget closeout o Obtain and process FCPA documentation in a timely manner

• Meeting Planning:

o Organize meetings (create & track study memos/letters/protocols)

o Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

• Contributes strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

• Mentors / buddies junior CTCs on process requirements Experience Required Minimum 3-5 years in Clinical Research or relevant healthcare experience

Educational Requirements

B.A./B.S. (Life Science preferred) or equivalent healthcare experience

CORE Competency Expectations

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills

• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• Hands on knowledge of Good Documentation Practices

• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.

• ICH-GCP Knowledge appropriate to role

• Excellent negotiation skills for CTCs in finance area

Behavioural Competency Expectations

• Highly effective time management, organizational and interpersonal skills, conflict management

• Effective communication with external customers (e.g. sites and investigators)

• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

• Demonstrates commitment to Customer focus.

• Able to work independently taking full ownership of delegated tasks

• Proactive attitude to solving problems / proposing solutions

• Positive mindset, growth mindset

• Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

  • FSP CTC(Shanghai)

    4 weeks ago

    Pu Dong Xin Qu, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

    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...

  • FSP CRA I

    6 months ago

    Pu Dong Xin Qu, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

    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. With over 19,000 staff...

  • FSP CRA I

    7 months ago

    Pu Dong Xin Qu, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

    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. With over 19,000 staff...

  • FSP CRA II

    7 months ago

    Pu Dong Xin Qu, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

    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. With over 19,000 staff...

  • FSP CRA II（Wuhan）

    6 months ago

    Pu Dong Xin Qu, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

    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. With over 19,000 staff...

  • Senior Culinary Director

    1 month ago

    Huang Pu Qu, China The Peninsula Shanghai Full time

    We are seeking an exceptional Senior Culinary Director to join our prestigious culinary team at The Peninsula Shanghai. As a senior leader, you will be responsible for achieving the company's objectives and creating a memorable guest experience.Work in a luxurious environment with an award-winning hotel groupReport directly to the Executive Chef and lead a...

  • Senior Director, China Search

    6 months ago

    Pu Dong Xin Qu, China 10287 GlaxoSmithKline (China) R&D Company Limited Full time

    The Senior Director of China Search and Evaluation is a senior role in the R&D organization at GSK, where the role holder supports global business development and licensing initiatives and has a direct impact on the success of the strategy and portfolio. The Search and Evaluation (S&E) group is responsible for proactively scouting external innovation to...

  • Senior Culinary Leader

    2 months ago

    Huang Pu Qu, China The Peninsula Shanghai Full time

    **Executive Sous Chef Opportunity at The Peninsula Shanghai**We are seeking a highly skilled and experienced Executive Sous Chef to join our team at The Peninsula Shanghai. As a senior leader in our kitchen, you will be responsible for coordinating and assisting the Executive Chef in leading the kitchen team and collaborating with other departments to...

  • Clinical Trial Specialist

    1 month ago

    Pu Dong Xin Qu, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

    About UsSHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access and...

  • Executive Pastry Chef

    7 months ago

    Huang Pu Qu, China The Peninsula Shanghai Full time

    The Peninsula Shanghai is now recruiting for an Executive Pastry Chef who has a strong experience in creating, planning, directing and participating in all aspects of the day to day operation of the Pastry and Bakery Kitchen. An exceptional opportunity to join our high-profile flagship hotel in Shanghai. The Peninsula Hotels espouses luxury...

  • Executive Culinary Artisan

    2 months ago

    Huang Pu Qu, China The Peninsula Shanghai Full time

    The Peninsula Shanghai seeks an exceptional Executive Pastry Chef to lead our Pastry and Bakery Kitchen team.Key Responsibilities:Develop and implement innovative pastry creations to elevate our culinary offerings.Manage daily operations, ensuring seamless execution of menu items and high-quality standards.Collaborate with the Food and Beverage team to drive...

  • Chief Pastry Artisan

    1 month ago

    Huang Pu Qu, China The Peninsula Shanghai Full time

    The Peninsula Shanghai is currently seeking a highly skilled Chief Pastry Artisan to join our esteemed culinary team. As the head of the Pastry and Bakery department, you will play a pivotal role in creating exceptional guest experiences through your artistry and unwavering commitment to excellence.Key ResponsibilitiesPromote The Peninsula Shanghai as a...

  • Executive Sous Chef

    7 months ago

    Huang Pu Qu, China The Peninsula Shanghai Full time

    Working alongside a high profile and prestigious team, we are seeking an Executive Sous Chef to achieve the company’s objectives and create a memorable guest experience. Work for an award-winning luxury hotel group Report directly to Executive Chef and be a senior leader  An exceptional opportunity to join our high-profile flagship hotel...

  • Commercial Director-Waldorf Astoria Shanghai Qiantan

    7 months ago

    Huang Pu Qu, China Hilton Full time

    Commercial Director-Waldorf Astoria Shanghai Qiantan( Job Number: HOT0AMOZ) Work Locations :Waldorf Astoria Shanghai QiantanSouth of Oriental Sports Centre, Pudong New DistrictShanghai200002 With thousands of hotels in over 100 countries and territories, Hilton offers countless opportunities to delight. From an open door to a welcoming smile and an...

  • Director of Finance-Waldorf Astoria Shanghai Qiantan

    7 months ago

    Huang Pu Qu, China Hilton Full time

    Director of Finance-Waldorf Astoria Shanghai Qiantan( Job Number: HOT0AMP3) Work Locations :Waldorf Astoria Shanghai QiantanSouth of Oriental Sports Centre, Pudong New DistrictShanghai200002 With thousands of hotels in over 100 countries and territories, Hilton offers countless opportunities to delight. From an open door to a welcoming smile and an...

  • Senior Sales Development Manager for Beauty Products

    1 month ago

    Changning Qu, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full time

    Job DescriptionWe are seeking a highly motivated and results-driven Senior Sales Development Manager to join our team at Hydrafacial Trading (Shanghai) Co Ltd in China.Job SummaryThe ideal candidate will possess over three years of experience in sales, with exceptional communication skills and a strong customer service mindset. They will be responsible for...